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Regulatory & Government Affairs Counsel - Remote
Point 4.2
Remote regulatory agency director job
A financial services company based in Palo Alto is looking for an experienced Associate General Counsel to support regulatory compliance and government relations. The successful candidate will have a J.D., be eligible for in-house practice, and possess 4-7 years of relevant experience. Responsibilities include managing regulatory frameworks, collaborating with legislative representatives, and advocating for consumer finance standards. This role is remote-first, allowing flexibility while contributing to a mission-driven culture.
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A nonprofit organization focused on strengthening American democracy is seeking a Deputy Director. This role involves strategic planning, logistics management, and curriculum oversight for the Congressional Fellowship program. Ideal candidates will have a bachelor's degree, 3-6 years of relevant experience, and strong organizational skills. The position offers a salary between $80,000 and $110,000, with comprehensive benefits and a flexible work schedule.
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$80k-110k yearly 3d ago
Director, CMC Regulatory
Umoja Biopharma
Remote regulatory agency director job
Umoja Biopharma is an industry-leading biotech with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting-edge drug development. We are committed to our core values and principles that support our overall mission and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja to deliver on our goals. We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families.
Umoja Biopharma - Your Body. Your Hope. Your Cure.
POSITION SUMMARY
The Director, CMC Regulatory Affairs reports to the Head of Regulatory Affairs and is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support Umoja's drug products including, DMF, IND and NDA/BLA applications, Health Authority (HA) responses, and briefing packages (including participating in/leading CMC-specific HA meetings). This role will serve as a technical regulatory leader, providing expertise to support the development of our in vivo CAR-T therapy programs. This key role is critical to ensuring that process development activities support the global regulatory strategy and eventual licensure. This position will partner with the global regulatory lead in development and execution of the overall global regulatory strategy. This role builds and relies on critical partnerships with key stakeholders to execute the strategies in alignment with business priorities. This individual also performs regulatory assessments of proposed manufacturing changes and provides guidance on regulatory expectations throughout development.
The ideal candidate will bring deep experience in cell & gene therapy and a strong track record in oncology or rheumatology drug development.
We will consider candidates at either the Director or Senior Director level based on candidate's qualifications and experiences.
CORE ACCOUNTABILITIES
Specific responsibilities include:
Provide technical regulatory leadership and oversight for ongoing and planned in vivo CAR-T therapy programs.
Responsible for the development of the CMC regulatory strategy for submissions including DMFs, IND, NDA/BLA and CTD regulatory filings.
Lead technical modules and sections of global regulatory filings (IND/CTA/BLA/MAA submissions), working with global regulatory lead to set strategy for submissions of product registration documents for health authorities worldwide.
Interact with regulatory agencies and represent Regulatory CMC at HA meetings, including preparing subject matter experts (SMEs).
Independently provide phase-appropriate strategic guidance/input related to current regulatory requirements and expectations for clinical trial applications and marketing applications for development projects.
Coordinate, manage, and lead all CMC regulatory projects including management of budget, timelines, and submission planning.
Manage and ensure compliance with all CMC regulatory reporting requirements, including annual and periodic reports.
Independently manage and prioritize Phase 1 IND through late-stage projects.
Identify, communicate, and propose resolutions to both routine and complex issues.
Provide regulatory advice and guidance in the context of available and expected scientific data, regulatory guidance, and precedent to project teams to support decision making and program advancement.
Provide regulatory expertise to business development, investor relations, and partnership discussions as needed.
Collaborate closely with the global regulatory lead, translational medicine, preclinical, clinical, and technical teams to align overall strategy with scientific discoveries. Demonstrate ability to engage and effectively influence team members across multidisciplinary teams.
Stay current on emerging trends, competitors, and regulatory guidance in cell & gene therapy and oncology and/or autoimmune therapeutic areas. Conduct regulatory research to assess the impact of relevant global regulations, guidance, and current regulatory environment. Provide interpretation of regulatory authority feedback, policies, guidelines, and directives.
Work with external program partners collaboratively and effectively to deliver on contractual obligations while moving toward corporate goals and priorities.
The successful candidate will have:
Director Level: PhD/MS/BA in a relevant scientific field of study required with a minimum of 10/12/15 years of regulatory drug development experience respectively in the biotechnology or pharmaceutical industry. Successful track record of regulatory submissions and approvals.
Senior Director Level: PhD/MS/BA in a relevant scientific field of study required with a minimum of 12/15/15+ years of regulatory drug development experience respectively in the biotechnology or pharmaceutical industry. Successful track record of regulatory submissions and approvals.
Demonstrated expertise in cell & gene therapy, ideally with CAR-T or T-cell engaging modalities; experience in in vivo gene delivery a plus.
Strong knowledge of global CMC regulatory requirements for early- and late-stage development of gene and cell therapies.
Proven ability to interact with regulatory authorities.
Excellent communication, leadership, and cross-functional collaboration skills.
Passion for innovation and commitment to advancing transformative therapies for patients.
Physical Requirements:
Ability to travel (~20%) for team meetings and/or regulatory interactions as required. Some international travel possible.
Ability to sit for prolonged periods of time
Director Salary Range: $206,400 - $254,900
Senior Director Salary Range: $253,000 - $312,500
Benefits Offerings
Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 4% deferral. Umoja also provides a generous Paid Time Off policy, employee commuter benefits, and cell phone stipend. For a full breakdown of our benefits offerings, please see the Benefits section of our website.
$79k-125k yearly est. Auto-Apply 23h ago
Director, Energy Partnerships
National Audubon Society 4.1
Remote regulatory agency director job
About Audubon
The National Audubon Society is a leading nonprofit conservation organization with 120 years of science-based, community-driven impact, dedicated to protecting birds and the places they need, today and tomorrow. Birds are powerful indicators of our planet's health, acting as sentinels that warn us of environmental change and inspire action. Audubon works across the Western Hemisphere, driven by the understanding that what is good for birds is good for the planet. Through a collaborative, bipartisan approach across habitats, borders, and the political spectrum, Audubon drives meaningful and lasting conservation outcomes. With 800 staff and over 1.9 million supporters, Audubon is a dynamic and ever-growing force committed to ensuring a better planet for both birds and people for generations to come. Learn more at *************** and on Facebook, Twitter and Instagram @audubonsociety.
Position Summary:
Reporting to the Senior Director, Climate Strategy, the Director, Clean Energy Partnerships will play a central role in advancing Audubon's clean energy strategy by building and managing strategic partnerships with clean energy and transmission industries, relevant decisionmakers, and non-governmental organizations (national and local NGOs), and other stakeholders. This role will lead national-level outreach and relationship management with existing and prospective partners in the clean energy sector to ensure that Audubon's goals for bird conservation and climate mitigation are aligned with responsible renewable energy development and transmission capacity expansion.
The Director will serve as a key member of Audubon's climate team, representing the organization in external coalitions, convenings, and collaborative forums. Working in close coordination with Audubon's regional and state teams, federal policy team, and habitat leads, the Director will take a collaborative and solutions-oriented approach to advancing clean energy deployment that safeguards important bird habitats and biodiversity.
This position is national in scope and will require a highly collaborative team player who can build trust, communicate effectively across departments and disciplines, and support implementation of clean energy priorities across Audubon's distributed network.
Compensation:
Salary range based on geo-differentials:
$92,000 - $103,000 / year = National
$103,000 - $116,000 / year = Alaska, CA (not San Francisco), Connecticut, D.C., Chicago, Oyster Bay, NY
$115,000 - $129,000 / year = NYC (not Oyster Bay), San Francisco, Seattle
Additional Job Description
Essential Functions
In partnership with the Senior Director, Climate Strategy, support development and execution of Audubon's Clean Energy Initiative strategies aligned with its broader climate and conservation goals.
Identify, cultivate and manage strategic relationships with clean energy and transmission industry stakeholders, utilities, RTOs, and NGOs, identifying opportunities for collaboration and problem-solving.
Represent Audubon in national, regional and state coalitions, working groups, convenings, and other external engagements focused on clean energy and transmission development, including siting, permitting and operation of utility-scale wind, solar, and transmission infrastructure, encouraging best practices by developers that conserve birds and habitat while supporting clean energy.
Collaborate with state and regional Audubon teams to support and inform local clean energy and transmission engagement opportunities, ensuring alignment with national priorities and conservation opportunities.
Serve as a trusted resource and central point of contact for internal staff engaging with the clean energy and transmission sectors, providing coordination, guidance, and strategic insight.
Facilitate knowledge exchange and peer learning across Audubon's network to support clean energy and transmission engagement and partnership development.
Track and communicate emerging trends in the clean energy industry relevant to climate benefits and conservation of bird species and habitat, including policy development, siting and operation practices and research and implementation of new technologies that support avoiding, minimizing and mitigating impacts.
Support a culture of philanthropy, including public funding efforts in partnership with members of the Climate and Development teams, including proposal development, reporting, and donor engagement.
Work closely with Audubon's communications team to tell the story of Audubon's clean energy and transmission work, translating complex issues for broader audiences including decisionmakers, the Audubon Network of members and supporters including chapter members, and the general public.
Promote an organizational culture and structure that fosters cooperation, communication, collaboration, respect, teamwork, and trust.
Collaborate with colleagues across the Americas including through joint planning and execution of shared priorities.
Maintain and foster culture of safety.
Other job-related duties as assigned.
Qualifications and Experience:
10+ years progressive, professional experience in federal, state and/or local government relations, permitting policies for wind, solar and transmission, advocacy, public relations, and solid and verifiable conservation or natural resource management on species and habitat, clean energy collaboration, and/or public service. An equivalent combination of education and experience will also be considered.
Working knowledge of climate change and federal, state and/or local energy regulatory policy, strong understanding of permitting processes and relevant state and federal agencies, strong commitment to bird conservation, connections with leading experts in the fields and with funders of climate change work is plus.
Exceptional project management skills; including managing complex or multiple projects through to success, meeting project deadlines, and coordinating the work of key staff and partners.
A self-starter, one who is able to work collaboratively with staff at multiple career levels in a matrix organization.
Proven record of building and activating diverse coalitions to successfully advance policy or program outcomes.
Experience working in a decentralized organization that coordinates strategies for national, state and local legislative issues.
Strong interpersonal, oral, and written communication skills that can be adapted to reach a wide range of individuals and used to build consensus. Ability to synthesize and communicate technical and complex information to both technical and non-technical audiences.
Proficiency with Microsoft Office and other web-based project management products.
Must have a flexible approach to work, with a willingness to travel as needed.
Commitment to Audubon's organizational values of care, collaboration, change, integrity, impact, and innovation.
Experience fostering inclusive and collaborative work environments is valued.
National Audubon Society Competencies:
This role will also be accountable to apply and develop the following competencies.
Building Trust: Take actions that give others confidence in your intentions and see you as a truthful and reliable person who follows through on promises and commitments.
Coaching: Guide and develop individuals within the organization, nurturing their professional growth and enhancing performance for the future.
Decision Making: Make decisions based on comparative data and input from various sources, incorporating diverse viewpoints and insights for a holistic understanding.
Leading and Facilitating Change: Be effective in guiding, managing, and supporting organizational or systemic transformations, including considering diverse needs and perspectives.
Strategic Leadership: Demonstrate creative problem-solving skills and articulate strategic vision to help team members and the organization achieve long-term goals.
EEO Statement
We are an equal opportunity employer and do not discriminate based on race, color, religion, sex, national origin, age, disability, veteran status, or any other protected characteristic outlined by federal, state, or local laws. We are committed to providing an inclusive and accessible hiring process for all candidates.
Accessibility Statement
The National Audubon Society endeavors to keep our careers site accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact Accommodations@audubon.org. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
$115k-129k yearly Auto-Apply 60d+ ago
Director - Strategic Regulatory Services (Secret Clearance Required)
Raytheon 4.6
Remote regulatory agency director job
Country:
United States of America Hybrid
U.S. Citizen, U.S. Person, or Immigration Status Requirements:
Active and transferable U.S. government issued security clearance is required prior to start date. U.S. citizenship is required, as only U.S. citizens are eligible for a security clearance
Security Clearance:
DoD Clearance: Secret
RTX is an aerospace and defense company that provides advanced systems and services for commercial, military and government customers worldwide. It comprises four industry-leading businesses - Collins Aerospace Systems, Pratt & Whitney, Raytheon Intelligence & Space and Raytheon Missiles & Defense. Its 195,000 employees enable the company to operate at the edge of known science as they imagine and deliver solutions that push the boundaries in quantum physics, electric propulsion, directed energy, hypersonics, avionics and cybersecurity. The company, formed in 2020 through the combination of Raytheon Company and the United Technologies Corporation aerospace businesses, is headquartered in Arlington, VA.
The following position is to join our RTX Enterprise Services team:
Role Overview:
We are seeking a highly skilled, experienced, innovation-oriented and results-driven Director of Digital Strategic Regulatory Services (SRS) across the organization. This role is critical in ensuring the security, integrity, and resilience of our digital assets and information systems. The Director of SRS will be responsible for identifying and developing the implementation strategy for regulatory requirements across RTX (Domestic and International) to support the company's strategic objectives and operational effectiveness through delivery of efficient and effective compliance services.
The role will require a deep understanding of the regulatory landscape in aerospace and defense, the ability to lead through transformation, and successful partnership with key Enterprise functions. This role will evolve and lead an SRS program that is continuously monitoring and identifying new regulatory requirements and ensuring RTX is in the best position to comply.
The role requires and active Secret Clearance is order to be considered.
What You Will Do:
Define and implement a comprehensive global regulatory strategy that aligns with the company's strategic goals.
Ensures RTX global sites are compliant with digital policies, contractual requirements, and local regulations.
Strong understanding of global digital controls, risk management frameworks, standards, and best practices (e.g., Part-IS, ISO, NIS2, NIST, CMMC, GDPR, CIS, SCF).
Oversees the readiness of all unclassified Defense and Commercial systems for broad based assessment and certification including NIS2, Part-IS, ISO27001, AUS DISP, UK Cyber Essential/+, and CMMC, etc..
Inform, adopt and implement an operational strategy that leverages innovation and incorporates a Unified Controls Framework (UCF) across regulatory requirements to enable a test once use many approach to streamline assessments.
Define, implement, operate and report on key performance indicators (KPIs) and key risk indicators (KRIs) metrics related to SRS.
Lead the identification, assessment, prioritization and reporting of digital controls non-compliance risks across external assessments such as Part-IS, CMMC, DIBCAC, ISO, etc..
Lead and mentor a team of digital regulatory & controls professionals through transformation, fostering a culture of continuous improvement and innovation while inspiring to embrace RTX's core values
Collaborate with cross-functional teams, including IT, cybersecurity, audit, legal, and compliance, to ensure a cohesive approach to regulatory & policy testing and assessment.
Partner with other functions to drive the development and implementation of controls to safeguard digital assets and ensure compliance with industry standards and regulations.
Serve as a subject matter expert on digital regulatory & policy matters, providing guidance and support to business units and stakeholders.
Travel 25%.
Qualifications You Must Have:
A University Degree in Business, Science, Technology, Engineering or Mathematics and a minimum of 14 years of prior relevant experience, or an Advanced Degree in a related field and a minimum of 12 years of relevant experience.
Minimum of 12 years of experience in digital controls, cybersecurity, capability maturity or a related discipline, with at least 5 years in a leadership role.
Active and transferable U.S. government issued security clearance is required prior to start date. U.S. citizenship is required, as only U.S. citizens are eligible for a security clearance.
Qualifications We Prefer:
Preferably 5+ years of experience in a top-tier risk advisory or management consulting firm.
Proven track record of successfully managing digital controls programs in large, complex organizations, preferably within the Aerospace and Defense industries.
Ability to communicate with all levels of management verbally and written, facilitate effective meetings, build effective working relationships and partnerships, and strong interpersonal skills.
Excellent analytical, problem-solving, and decision-making skills.
Relevant certifications such as CISSP, CISM, CRISC, or similar are desirable.
Highly proficient in Microsoft Office products with experience in preparing presentations and presenting to executive leadership
Expert knowledge of national and international laws, regulations, policies, and ethics as they relate to cybersecurity (e.g., DFARS, FAR, ITAR, EAR, NIST 800-53, NIST 800-171)
General knowledge of IT, Artificial Intelligence, and cybersecurity with experience in the following areas: incident response, business continuity/ disaster recovery, vulnerability management, application security, database security, identity & access management, OT security, cloud security, third-party & supply chain risk management
What We Offer: Whether you're just starting out on your career journey or are an experienced professional, we offer a robust total rewards package with compensation; healthcare, wellness, retirement and work/life benefits; career development and recognition programs. Some of the benefits we offer include parental (including paternal) leave, flexible work schedules, achievement awards, educational assistance and child/adult backup care.
Learn More & Apply Now!
Work Location: Remote
Please consider the following role type definition as you apply for this role:
Remote: This position is currently designated as remote. However, the successful candidate will be required to work from one of the 50 U.S. states (excluding U.S. Territories). Employees who are working in Remote roles will work primarily offsite (from home). An employee may be expected to travel to the site location as needed.
The salary range for this role is 176,000 USD - 352,000 USD. The salary range provided is a good faith estimate representative of all experience levels. RTX considers several factors when extending an offer, including but not limited to, the role, function and associated responsibilities, a candidate's work experience, location, education/training, and key skills.Hired applicants may be eligible for benefits, including but not limited to, medical, dental, vision, life insurance, short-term disability, long-term disability, 401(k) match, flexible spending accounts, flexible work schedules, employee assistance program, Employee Scholar Program, parental leave, paid time off, and holidays. Specific benefits are dependent upon the specific business unit as well as whether or not the position is covered by a collective-bargaining agreement.Hired applicants may be eligible for annual short-term and/or long-term incentive compensation programs depending on the level of the position and whether or not it is covered by a collective-bargaining agreement. Payments under these annual programs are not guaranteed and are dependent upon a variety of factors including, but not limited to, individual performance, business unit performance, and/or the company's performance.This role is a U.S.-based role. If the successful candidate resides in a U.S. territory, the appropriate pay structure and benefits will apply.RTX anticipates the application window closing approximately 40 days from the date the notice was posted. However, factors such as candidate flow and business necessity may require RTX to shorten or extend the application window.
RTX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans' Readjustment Assistance Act.
Privacy Policy and Terms:
Click on this link to read the Policy and Terms
$69k-99k yearly est. Auto-Apply 60d+ ago
Director of Customer Success - Energy Management
Gridium 3.8
Remote regulatory agency director job
Gridium's mission is to hasten the transition to a low-carbon economy. We are looking for a Director of Customer Success to help us lead the management of the next generation of energy and operations software tools for buildings. This is a senior level position focused on account management, customer success leadership, driving net revenue retention and account expansion.
About the job
The Director of Customer Success will be responsible for customer success and strategic account expansion matters. This includes:
Managing the commercial relationship for key accounts, including renewals and identifying expansion opportunities, while partnering with Sales on new business opportunities.
Managing the workload and work product of a team of Energy Managers and Energy Analysts.
Directing the commercial focus of the Customer Success team, ensuring that technical delivery and energy analysis directly support retention and expansion goals.
Working directly with a set of assigned customers to achieve deep energy savings in their buildings by providing them with senior level advice and expertise on energy management, building operations, utility bills/rates, sustainability, and other topics related to energy use in commercial real estate.
Working with the Customer Success and Sales teams to develop account plans that map customer objectives to Gridium's value, then using commercial health insights to surface churn risks early and guide targeted retention and expansion actions.
Building and maintaining strong, long lasting executive level customer relationships.
Ensuring the timely and successful delivery of our solutions according to customer needs and strategic objectives.
Requirements
Extensive (7+ years) prior work experience in a Customer Success or Account Management role. Preference will be given to candidates with significant experience in Energy Management, Sustainability, Facilities Engineering or Commercial Real Estate.
Demonstrated experience in a senior or leadership capacity, including managing the work product of a team, mentoring, or leading complex projects.
Demonstrated experience owning a revenue or retention quota in a customer success or account management capacity is required.
Strong business acumen and judgment and a proven ability to negotiate and close account expansion deals. The position will be measured on revenue goals from retention and expansion.
Track record of influencing commercial outcomes within existing customers through value realization, executive alignment, or identifying expansion ready use cases.
Ability to travel monthly to visit in person with customers.
Bachelor's degree required. Master's degree in a relevant area preferred.
Prior experience with advanced energy and/or financial spreadsheet modeling.
Experience in Energy Management. Preference will be given for candidates with a CEM or similar certification.
You must currently live in and have the legal right to work in the United States.
Salary and Benefits
This role offers a base salary between $130,000 and $150,000, depending on experience, plus a target annual commission of approximately $40,000, bringing total on-target earnings to $170,000-$190,000. The compensation package also includes an equity grant, a 401(k) with 4% match, a great health plan, vision, dental, generous parental leave, and a flexible vacation policy - we want you to take the time off you need so that you are happy and productive.
About Gridium
Gridium is a venture-backed SaaS application provider with a mission to bring cost-effective energy savings to commercial real estate. We have been delivering deep energy savings to our customers for fourteen years, and we are now growing faster than ever due to increasing demand for real energy solutions.
We have been an all-remote company since our founding, and we love the flexibility it affords. Remote work allows you to structure your day with minimal interruption so that you can get stuff done in the style that makes most sense for you. (And if for you that means an office in a coworking space, we'll provide that too.)
Spending time face-to-face is important, so several times each year we pick a city and meet up for several days of highly productive and fun planning and doing. We have a casual, cooperative work environment where everyone's ideas matter.
And of course
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
$170k-190k yearly Auto-Apply 50d ago
Director, Energy Origination
Hut 8 Mining 3.6
Remote regulatory agency director job
ABOUT HUT 8
Imagine the ultimate destination for those who want to work at the cutting edge of technology, energy, and infrastructure. Hut 8 is on a mission to build and operate some of the world's largest data centers for next-generation computing workloads, including AI, Colocation, Cloud, and Bitcoin Mining. We are proud to offer interesting and challenging opportunities for individuals who want to build teams, solve problems, and make an impact from day one. If you're an ambitious individual looking for a career that is as rewarding as it is challenging, you've come to the right place.
ABOUT THE ROLE
We are seeking a highly motivated and experienced Director, Energy Origination who will manage data center development opportunities across the United States and manage early-stage efforts to execute on these opportunities by securing project site control and interconnection positions.
You will conduct project due diligence, secure site control, and navigate the load interconnection queue for data center development projects in PJM, MISO, ERCOT, SPP, WECC, and the Southeast. This role requires exceptional leadership skills, strategic thinking, and the ability to collaborate with cross-functional teams to ensure successful development and integration of data center loads. The Director of Development will report to the SVP of Corporate Development.
Some of the key responsibilities you should expect are the following:
The purpose of the Director of Energy Origination is to generate, develop, and execute a pipeline of competitive, data center development sites.
Oversee the entire development lifecycle for data center loads, including site selection, permitting, grid interconnection, and commercial offtake negotiations. Ensure all projects are delivered on time and within budget.
Proven ability to negotiate commercial terms with counterparties to maximize value for the company. This includes interactions with customers, project partners, EPC/supplier contracts, transmission providers, landowners, taxing authorities/entities, and O&M contracts.
Proven ability to identify strategic business opportunities and mitigate risks through well-structured project contracts.
Conduct risk assessments and business impact analyses while evaluating relevant laws and regulations.
Strong understanding of financial drivers and a customer-centric approach, working closely with stakeholders from C-Level executives to procurement personnel.
Lead data center development opportunities across the United States and manage development budgets to create investment opportunities.
Develop and implement growth strategies while fostering collaboration across functional areas to achieve shared goals.
Provide direction to internal teams, including engineering, legal, and finance, to support successful project outcomes.
Frequent travel required to engage key stakeholders and spearhead project approvals.
Prepare and present transaction approval documentation for senior management and participate in strategy development and execution planning.
Represent the company at public hearings, industry forums, and stakeholder meetings. Build coalitions with industry partners to address legislative challenges and advance company interests in data center development.
ABOUT YOU
Bachelor's degree in Engineering, Environmental Science, Business, or a related field
Minimum of 6 years of experience in energy origination and/or development. Experience with data center development is a plus.
Strong financial acumen and business strategy expertise, with experience in executive-level presentations.
Exceptional interpersonal skills, thriving in fast-paced, entrepreneurial environments while meeting deadlines.
Highly organized with strong attention to detail.
Ability to collaborate effectively in a flat organizational structure, leveraging diverse expertise.
Skilled in multi-tasking and managing conflicting priorities, taking ownership of tasks.
ABOUT THE WORK ENVIRONMENT
This role is remote or in office at our corporate headquarters in the Brickell area of Miami, Florida. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
WHAT MAKES HUT 8 A GREAT PLACE TO WORK
Hut 8 offers a benefits and wellness program that includes medical, dental, vision, life, and short-term and long-term disability insurance, as well as paid time off. We are proud to invest in building the best team in the industry. At all levels of the organization, we are driven by an entrepreneurial spirit, radical transparency, and relentless growth mentality.
At Hut 8, you will have the opportunity to:
▶ Work with bright, driven peers from a range of educational and professional backgrounds including software development, energy, engineering, entrepreneurship, investment banking, private equity, and management consulting
▶ Design and pitch new products, services, and other initiatives to a leadership team consisting of serial entrepreneurs and seasoned executives and backed by a board of directors consisting of industry veterans of energy, finance, and government
▶ Debate ideas and alternatives in a truly meritocratic setting where the learning curve is steep and the lessons come from both senior and junior members of the team
▶ Build a lifelong network of friends and professional connections at the cutting-edge intersection of technology, energy, and infrastructure
$91k-142k yearly est. Auto-Apply 17d ago
Nuclear Director, Energy + Utilities
Jensen Hughes 4.5
Remote regulatory agency director job
Throughout our worldwide network of experts, clients and communities, we are renowned for our leadership in fire protection engineering - a legacy of responsibility we have proudly upheld since 1939. Today, our expertise extends broadly across closely related security and risk-based fields - from accessibility consulting and risk analysis to process safety, forensic investigations, security risk consulting, emergency management, digital innovation and more.
Our engineers and consultants collaborate to solve complex safety and security challenges, ensuring our clients can protect what matters most. For over 80 years, we have helped mitigate risks that threaten lives, property and reputations. Through technology, expertise and industry-leading research, we remain dedicated to our purpose of making our world safe, secure and resilient.
At Jensen Hughes, we believe that creating and sustaining a culture of trust, integrity and professional growth starts with putting our people first. Our employees are our greatest strength, and we value the unique perspectives and talents they bring to our organization.
Our wide range of Global Employee Networks connect people from across the organization, supporting career development and providing forums for individuals to share experiences on topics they're passionate about. Together, we are cultivating a connected culture where everyone has the opportunity to learn, grow and succeed together.
Job Overview
Jensen Hughes, a leading consulting firm specializing in risk analysis and engineering solutions, is actively seeking a Nuclear Director of Energy & Utilities to lead and grow our nuclear team across the UK. This is a senior leadership role that combines technical expertise with business development, commercial acumen, and team leadership. The successful candidate will be a recognised expert in nuclear fire engineering and safety, capable of shaping our nuclear offering and driving growth in this sector.
Responsibilities
Lead and deliver fire hazard assessments (FHA), fire safety strategies, fire PSA, and related safety studies in compliance with UK regulatory frameworks.
Provide technical leadership across nuclear projects, ensuring high-quality outputs for clients.
Support and review safety cases, risk assessments, and design justifications related to fire safety.
Represent Jensen Hughes in client and regulator engagements, supporting technical discussions, reviews, and approvals.
Drive business development activities: identify opportunities, lead proposals, and build client relationships across the UK nuclear sector.
Play a key role in shaping the commercial strategy for nuclear within the UK Energy & Utilities sector.
Mentor, develop, and expand the nuclear team, fostering talent and building capability for long-term growth.
Collaborate with multi-disciplinary teams across Jensen Hughes to deliver integrated services.
Stay ahead of evolving regulations, British Standards, IAEA guidelines, and ONR guidance.
Requirements and Qualifications
Extensive, credible experience in nuclear fire engineering and safety within the UK context.
Proven ability to deliver Fire Hazard Analyses, fire PSA, and safety case contributions for UK nuclear licensees.
Strong business development skills, with a track record of winning and growing client accounts.
Commercial acumen, able to contribute to proposals, pricing, and strategy.
Chartered Engineer (CEng) or equivalent professional recognition (e.g., MIFireE, IMechE, IET).
Degree in Fire Engineering, Mechanical Engineering, Nuclear Engineering, or a related technical discipline.
Eligibility for UK Security Clearance (SC) as a minimum.
Preferred
Prior experience in GDA, new reactor design licensing, or high-hazard facility projects.
Familiarity with ONR Safety Assessment Principles (SAPs) and Technical Assessment Guides (TAGs).
Engagement with EDF, Sellafield Ltd, Magnox, or international nuclear operators.
Conditions of Employment
Employment is conditional on the ability to obtain and maintain UK Government Security Clearance (SC level or above).
A full background and financial check will be conducted as part of the vetting process.
#LI-JC1
Jensen Hughes is an Equal Opportunity Employer. Qualified candidates will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
At Jensen Hughes, we embrace innovation and understand that people are increasingly using artificial intelligence (AI) tools like ChatGPT and other generative platforms to learn, prepare and communicate. We have provided some guidelines regarding the responsible use of AI in the recruitment process. Please click here to review.
The security of your personal data is important to us. Jensen Hughes has implemented reasonable physical, technical, and administrative security standards to protect personal data from loss, misuse, alteration, or destruction. We protect your personal data against unauthorized access, use, or disclosure, using security technologies and procedures, such as encryption and limited access. Only authorized individuals may access your personal data for the purpose for which it was collected, and these individuals receive training about the importance of protecting personal data. Jensen Hughes is committed to compliance with all relevant data privacy laws in all areas where we do business, including, but not limited to, the GDPR and the CCPA. Additionally, our service providers are contractually bound to maintain the confidentiality of personal data and may not use the information for any unauthorized purpose.
*Policy on use of 3rd party recruiting agency for direct placements
Jensen Hughes will occasionally augment a recruiting search through agencies for certain positions when business conditions warrant. Jensen Hughes will not accept resumes, inquiries or proposals from recruiting agencies as an acceptable method to consider a candidate. 3rd party recruiting agencies must sign a standard Jensen Hughes agreement after being evaluated and accepted by a Human Resources or Talent Acquisition manager, or member of the talent acquisition team. Hiring managers and employees of Jensen Hughes are not authorized to accept resumes, engage in fee-based searches through recruiting firms or sign a search agreement. Please note this policy does not apply to “staffing firms” or firms that are involved with hiring temporary staff. Any recruiting agency interested in being considered may contact our recruiting team at jensenhughesrecruiting.com.
$72k-109k yearly est. Auto-Apply 1d ago
Director, Energy Delivery, NA
Vantage Data Centers 4.3
Regulatory agency director job in New Albany, OH
Vantage Data Centers powers, cools, protects and connects the technology of the world's well-known hyperscalers, cloud providers and large enterprises. Developing and operating across North America, EMEA and Asia Pacific, Vantage has evolved data center design in innovative ways to deliver dramatic gains in reliability, efficiency and sustainability in flexible environments that can scale as quickly as the market demands.
Energy Department
The Energy Department is dedicated to managing and optimizing the energy resources required to power our data centers while promoting sustainability and efficiency. The Energy department plays a critical role in ensuring our power solutions are cost-effective, support speed to market, have sufficient scale to meet growing AI load, and resilient to energy market fluctuations. The team focuses on energy procurement from utilities, independent power producers (IPPs), energy marketers, and renewable energy technology providers.
Position Overview
This role can be based in any of our US locations: Denver, CO; Phoenix, AZ; Quincy, WA; Santa Clara, CA; or Ashburn, VA.
The Director, Energy Delivery, NA will lead the strategic development and execution of comprehensive energy solutions for hyperscale data centers, including utility-supplied power and onsite generation (e.g., renewable energy, battery storage, microgrids). This role is responsible for end-to-end energy project development, from concept through commissioning, ensuring alignment with business objectives, customer commitments, and sustainability goals. The ideal candidate will combine technical expertise in power infrastructure and distributed generation with strong leadership and stakeholder management skills.
Essential Job Functions
Strategic Leadership & Planning
* Develop and execute energy strategies for data center campuses, including utility interconnections, onsite generation and microgrid solutions.
* Drive solutioning for complex energy projects, including hybrid systems integrating renewables, storage, and backup generation.
Project Development & Execution
* Lead projects from inception through delivery, managing scope, schedule, and budget for utility and onsite generation solutions.
* Oversee feasibility studies for distributed energy resources (DER), microgrids, and resiliency solutions.
* Negotiate utility agreements, PPAs, and other commercial models.
Stakeholder Engagement
* Serve as the primary point of contact for utilities, regulators, and technology partners for onsite generation systems.
* Collaborate with internal teams (Legal, Construction, Engineering, Operations) to ensure seamless integration of onsite assets.
Innovation & Sustainability
* Evaluate emerging technologies such as solar PV, wind, battery energy storage systems (BESS), and small modular reactors (SMRs).
* Support corporate sustainability objectives through clean energy and carbon reduction strategies.
Reporting & Governance
* Provide executive-level reporting on project progress, risks, and mitigation strategies, OpEx / CapEx.
* Ensure compliance with regulatory requirements and industry standards for both grid and onsite systems.
Additional Duties:
* Handle additional duties as assigned by Management.
Job Requirements
Education:
* Bachelor's degree in Engineering, Business, or related field; Master's preferred.
Experience:
* 10+ years in energy infrastructure development, including onsite generation or distributed energy projects.
Skills:
* Expertise in utility processes and distributed generation technologies.
* Strong leadership and cross-functional collaboration skills.
* Ability to manage complex projects under tight timelines.
* Travel required is expected to be up to 40% but may increase over time as the business evolves.
Physical Demands and Special Requirements
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to handle, or feel objects; reach with hands and arms; climb stairs; balance; stoop or kneel; talk and hear. The employee must occasionally lift and/or move up to 25 pounds.
Additional Details
* Salary Range: $180,000-$200,000 Base + Bonus (this range is based on Colorado market data and may vary in other locations)
* This position is eligible for company benefits including but not limited to medical, dental, and vision coverage, life and AD&D, short and long-term disability coverage, paid time off, employee assistance, participation in a 401k program that includes company match, and many other additional voluntary benefits.
* Compensation for the role will depend on a number of factors, including your qualifications, skills, competencies, and experience and may fall outside of the range shown.
#LI-Hybrid #LI-AT1
We operate with No Ego and No Arrogance. We work to build each other up and support one another, appreciating each other's strengths and respecting each other's weaknesses. We find joy in our work and each other, actively seeking opportunities to inject fun into what we do. Our hard and efficient work is rewarded with an above market total compensation package. We offer a comprehensive suite of health and welfare, retirement, and paid leave benefits exceeding local expectations.
Throughout the year, the advantage of being part of the Vantage team is evident with an array of benefits, recognition, training and development, and the knowledge that your contribution adds value to the company and our community.
Don't meet all the requirements? Please still apply if you think you are the right person for the position. We are always keen to speak to people who connect with our mission and values.
Vantage Data Centers is an Equal Opportunity Employer
Vantage Data Centers does not accept unsolicited resumes from search firm agencies. Fees will not be paid in the event a candidate submitted by a recruiter without an agreement in place is hired; such resumes will be deemed the sole property of Vantage Data Centers.
We'll be accepting applications for at least one week from the date this role is posted. If you're interested, we encourage you to apply soon-we're excited to find the right person and will keep the role open until we do!
$180k-200k yearly Auto-Apply 41d ago
Manager, Political Affairs
Edison Electric Institute 4.2
Remote regulatory agency director job
Job Description
WHO WE ARE
The Edison Electric Institute (EEI) is the association that represents all U.S. investor-owned electric companies. Our members provide electricity for more than 220 million Americans and operate in all 50 states and the District of Columbia. As a whole, the electric power industry supports more than 7 million jobs in communities across the United States.
EEI employees are required to work in office Monday-Thursday, and have the option to work remotely on Fridays.
KEY RESPONSIBILITIES OF THE MANAGER, POLITICAL AFFAIRS:
The Manager, Political and External Affairs plays a critical role in advancing EEI's federal political engagement strategy by supporting the Senior Director across three core areas: PAC fundraising, industry event management, and political programming.
The Manager serves as the internal lead for PowerPAC fundraising, driving engagement from member companies. The Manager collaborates closely with the PAC Steering Committee and EEI leadership to meet annual fundraising goals, manage the PowerPAC budget, track performance, and ensure full compliance with all reporting requirements. The Manager also produces treasurer's reports, maintains donor and disbursement records, and provides background materials to support contribution decision-making.
Other important responsibilities of the Manager, Political Affairs:
Support the Senior Director in executing PowerPAC's fundraising strategy, helping to engage all eligible groups and member companies to meet annual fundraising goals.
Assist in developing PAC campaigns, strengthening relationships, and identifying opportunities to expand PAC participation and visibility.
Assist in managing the PowerPAC budget, including tracking fundraising totals, monitoring financial activity, preparing candidate disbursements, and supporting PAC Steering Committee operations.
Prepare treasurer's reports and write detailed memos summarizing political background information, candidate assessments, and related analysis.
Play a central role in planning and executing EEI's major political and industry events, ensuring operational excellence and strategic alignment with EEI's advocacy objectives.
Provide operational, financial, and compliance support to the Senior Director, including processing invoices; coordinating with the General Counsel's office on contracts; and preparing materials for the semiannual LD-203 contributions report.
Administer the charitable PAC match program, ensuring accuracy and timely processing on behalf of EEI employees who contribute to PowerPAC.
REQUIRED & PREFERRED QUALIFICATIONS:
A bachelor's degree in Political Science, Communications, Public Policy, or a related field is required.
6-8 years of experience in PAC management, political fundraising, political operations, or planning high-level political or industry events is required.
Demonstrated ability to research, interpret, and analyze political trends and developments.
Exceptional written and verbal communication skills with experience drafting policy briefs, analytical reports, and background materials for senior leaders, elected officials, or policymakers.,
Strong technical and administrative skills, including proficiency with Office 365 and Microsoft Office applications, and the ability to learn internal accounting and budgeting systems.
Strong organizational skills and the ability to take initiative, manage competing priorities, and complete projects in a timely manner are essential.
Travel requirement: 10%.
COMPENSATION
The salary range for role is $80,000-125,000. Starting annual salary will be determined on individual qualifications. We offer a competitive benefits package that includes medical, dental, vision, 401k, paid time off, tuition assistance, wellness incentives and programs, transportation subsidy, and professional development opportunities. The role is eligible for a performance based bonus for the 2026 calendar year which is paid out the following March.
PHYSICAL AND SENSORY DEMANDS
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EEI is committed to providing a productive and safe environment. To achieve that goal, we conduct background and reference check investigations for all final applicants being considered for employment. Equal Opportunity Employment M/D/F/V.
$80k-125k yearly 4d ago
Director, AEBDM, Build States
Everway
Remote regulatory agency director job
At Everway (formerly n2y/Texthelp), our goal is to lead the world in Neurotechnology software, helping transform the way we understand and are understood.
We're a global community of over 500 team members spanning seven countries, including the UK, USA, Norway, Denmark, Sweden, Australia, and New Zealand. By understanding and addressing the unique needs of each individual, we're creating a world where differences are recognized and valued. A world where everyone can thrive.
We can only achieve our goals and continue to grow by having high performing people in our team, people who share our goals and are passionate about our mission. We pride ourselves on our core values that are embedded within our culture. These are to be curious, have courage, and commit fully.
Join us at Everway - together, we can unlock the full potential of every mind.
About the Role
Everway is seeking a high-energy, strategic, and "player-coach" Director of AEBDM to lead our expansion across the "Build States." This role is critical to our mission of disrupting the EdTech space and improving educational attainment for students across Middle America.
As the leader of our Build States region, you will be a territory architect. You will manage an initial team of seven Inside Sales Representatives overseeing four high-performers and leading the recruitment and onboarding of three new hires. You will be responsible for turning underserved territories into high-growth engines, hitting a team quota of $3.5M, and instilling a culture of sales excellence and operational rigor.
Main Responsibilities Team Leadership & Talent Growth
Hiring & Onboarding: Manage the end-to-end recruitment, training, and ramp-up of three new ISRs to bring the team to full capacity.
Coaching: Conduct weekly 1:1s, live call coaching, and professional development reviews to master the Everway sales process.
Performance Management: Proactively manage direct reports by reviewing objectives and providing actionable feedback to enhance individual and team win rates.
Strategic Market Development
Whitespace Strategy: Research and profile "Build State" territories, creating account maps to identify key decision-makers within K-12 and Higher Ed institutions.
Collaboration: Liaise with Marketing and Product teams to formulate sales strategies and messaging that resonate specifically with Middle America educational leaders.
Complex Sales Support: Participate directly in complex sales situations and negotiations to support your team in closing high-value deals.
Operational Excellence & Forecasting
Pipeline Management: Ensure the team follows up on all MQLs and leads within a maximum 24-business hour window.
Forecasting Accuracy: Maintain a highly accurate team forecast with weekly reviews, providing detailed activity reports to the SVP of Sales.
Sales Velocity: Monitor and prioritize the team's workload to move opportunities through the pipeline with high velocity and urgency.
Hand-over Integrity: Oversee the transition of newly won customers to the implementation team to ensure long-term customer satisfaction and student impact.
Measures of Success
Quota Attainment: Achieving the $3.5M annual revenue target through consistent quarterly performance.
Pipeline Coverage: Maintaining pipeline coverage in line with quarterly targets (e.g., 3x-4x coverage).
Efficiency Metrics: Optimizing the win:loss ratio, reducing "time in pipe," and meeting lead follow-up SLAs.
Team Development: Successful ramp-up of new hires and the internal promotion/growth of existing ISRs.
Essential Criteria
Experience: 3-5+ years of experience successfully managing a SaaS sales team (EdTech experience highly preferred).
The "Builder" Mentality: A proven track record of taking underserved or "small" territories and scaling them into high-growth regions.
K-12/Higher Ed Knowledge: Deep understanding of the USA educational procurement cycle, including engagement with Tech Integration Specialists, Title I Directors, and Administrators.
Leadership: Strong ability to coach early-career talent and a "player-coach" willingness to join sales calls.
Technical Proficiency: Expert knowledge of CRM (Salesforce) for pipeline management and forecasting.
Desirable Criteria
Communication: Confident presenter with the ability to share a compelling vision with both internal stakeholders and educational leaders.
Adaptability: Ability to thrive in a rapidly growing, "rapid-response" environment.
Vision: Demonstrated passion for improving educational outcomes and building a world-class sales culture.
Please submit your application on our website by Monday 26 January 2026.
Please note: applications may close early due to high demand, so early submission is encouraged.
Join our team and enjoy a competitive salary with bonus opportunities, flexible work schedules, and comprehensive health and wellness benefits. We offer flexible time off plans, career growth through development programs, and a collaborative, innovative culture where your ideas matter. Ready to make an impact? Apply today and be part of a company that invests in your success!
We are committed to providing a Drug-Free Workplace for all employees.
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.
You can view our Recruitment and Selection Policy here.
Please click the link for our Privacy Notice
$76k-131k yearly est. Auto-Apply 3d ago
Deputy Director of Development
Movement Labs
Remote regulatory agency director job
Movement Labs is an incubator and consulting firm that uses technology, data, and experimentation to stop fascism and build progressive power. We help progressives win and defeat MAGA extremists through year-round work grounded in research and real-world testing. Our team partners with leading advocacy groups, grassroots organizers, and electoral campaigns to develop innovative tactics, win elections, and shift power for the long term.
As the R&D powerhouse for the progressive movement, we've run over 100 randomized control trials (RCTs) on voter behavior and helped hundreds of organizations increase their impact. We work hard, and the environment evolves rapidly. We are adaptable, nimble, and shift quickly as needed to meet the moment. We are looking for candidates that thrive in this type of environment.
The Deputy Director of Development is a senior revenue team member responsible for driving fundraising execution across multiple channels (individual giving, institutional/grants support, partnerships, and development operations). This role partners closely with the Director of Development to manage day-to-day development work, strengthen donor stewardship, improve systems and reporting, and support strategic growth. The Deputy Director will oversee key workflows, lead projects from planning through execution, and help ensure Movement Labs meets ambitious revenue goals with strong internal coordination and an excellent donor experience. This role is fully remote.
Responsibilities
Fundraising execution & pipeline
Manage and advance a portfolio of prospects/donors (cultivation → solicitation → stewardship), in coordination with the Director and principals.
Draft donor communications: proposals, pitch decks, impact updates, follow-ups, acknowledgements.
Support major gift moves management: contact reports, next steps, briefing memos, and meeting preparation.
Development operations & systems
Maintain the CRM: data hygiene, tagging, workflows, acknowledgements, reporting cadence.
Improve systems for donor stewardship (thank-you process, impact reporting calendar, renewal tracking).
Proposals/Grants & Cross-functional coordination
Coordinate proposal development timelines, internal inputs, and submission logistics.
Maintain grant deliverables calendar; support reporting and compliance processes.
Partner with Programs/Comms/Leadership to translate work into fundable narratives and donor-ready collateral.
Coordinate fundraising support for campaigns, rapid response moments, and special projects.
Team & leadership
Supervise senior development associate, possibly other roles as the team grows
Manage external contractors and vendors as needed
Document SOPs; drive process improvements; serve as backup to the Director when needed.
Requirements
Qualifications
Our preferred candidate will have many of these characteristics and experience:
3-5+ years in nonprofit/political fundraising
Demonstrated success managing donor/prospect pipelines and producing fundraising materials (proposals, updates, decks).
Strong project management: can run timelines, coordinate inputs, and deliver high-quality work under deadlines.
CRM fluency (e.g., EveryAction or similar)
Excellent writing and editing; comfort translating complex work into compelling funder language.
High discretion and comfort handling sensitive donor information.
Collaborative style and ability to work cross-functionally in a fast-changing environment.
Our preferred candidate may have some of these characteristics and experience:
Experience with 501(c)3, 501(c)4, and PAC giving.
Major gifts experience (qualification, solicitation support, stewardship strategy).
Grants experience (proposal coordination, reporting calendars, compliance).
Vendor management (digital fundraising, fundraising consultants, fiscal sponsor).
Experience in progressive advocacy/electoral ecosystem or aligned mission spaces, specifically those focused on experimenting and scaling evidence-based programs.
Benefits
Annual salary of $90,000-$105,000 as part of a transparent salary structure with clear levels of advancement, including geographic COLA depending on employee location.
Excellent health, dental, and vision benefits, 401(k) matching, and unlimited Paid Time Off.
This position is not eligible for the collective bargaining unit.
We're looking for candidates with a wide range of skills and experience. If you're excited about the job, even if you don't match all the characteristics, we encourage you to apply.
Applications submitted by January 12th will be given priority. The application process includes two interview rounds and an exercise. We hope our new Deputy Director of Development can start on March 1.
Applicants must be legally eligible to work in the United States.
$90k-105k yearly Auto-Apply 17d ago
Regulatory Affairs Lead, Oncology (Sr. Manager)
Astellas Pharma, Inc. 4.9
Remote regulatory agency director job
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at *****************
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
Purpose and Scope:
* Responsible for the development and successful execution of regulatory strategies, plans and processes for assigned projects and/or products with considerable technical complexity and diversity requiring impact on internal decision making. The assigned area responsibility may be focused on global and/or regional development compounds and new indications / formulations of commercial products and/or life cycle management of commercial products within a within a region.
* Responsible to be a Regional Regulatory lead or Global Regulatory Lead, for development programs (early stage of clinical development), or as a regulatory representative for commercial products requiring multifaceted problem solving and internal decision making.
* Collaborates to assure global and local regulatory strategies reflect best in class application of scientific, therapeutic and regulatory expertise and knowledge and ensures Astellas' programs meet all applicable regulatory and business requirements. Provides regional input and ensures regional alignment with regulatory strategies for global programs and products.
* Responsible for interacting with global and regional peers and regulatory management to align Astellas' regulatory strategies; influences internally and externally to contribute to project/product decision making ensuring viable regulatory approaches and interacts with regulatory agencies.
* Accountable for project-related and marketed product-related communications and interactions with project and/or product team members, regulatory authorities and health agencies requiring impact on decision making; incorporates regulatory environment trends to ensure the projects/products reflect up-to-date regulatory strategies.
* May lead an Extended Regulatory Team including Regional Regulatory Leads and other GRA professionals across regions and functions to develop and implement regulatory strategies and accomplish project/product objectives for global and/or regional products. Advises project/product teams in the application of regulatory strategies and solving of regulatory issues.
* Collaborates with Astellas GRA TA Heads and regions on global regulatory strategies and with Astellas functions for regional programs and products.
Responsibilities and Accountabilities:
Regulatory Excellence
* Leads the development, implementation and successful application of robust regulatory strategy input to assigned areas for submissions such as MAA, NDA and variations associated with early-stage development programs, development of new indications / formulations and/or commercial products and is accountable for the expert review of major deliverables from a regulatory perspective.
* Leads regulatory development in GRL or regional regulatory lead roles in the context of Development TAs and Core Teams and Regulatory Extended Teams for programs with considerable complexity requiring impact on internal and external decision making.
* Applies understanding of regulatory requirements and trends into the development of aligned regulatory strategies.
* Develops and contributes to the successful adoption and execution of appropriate regulatory strategies and processes, which ensure project and/or product programs meet established timelines and are aligned with Astellas' short and long-term business strategies and goals.
* Accountable for the preparation and submission of technical documents to regulatory authorities for assigned projects/products. Ensures data summaries from research, development, and manufacturing reports are adequate in content, quality, interpretation and regulatory/scientific rigor to drive success with regulatory authorities and builds consistency in the messaging of data globally. Responsible for execution of the regulatory strategy into regulatory applications (i.e. Scientific Advice, IND, MAA, NDA, BLA and variations) across assigned development projects and/or commercial products. Assures submissions reflect the best-in-class application of regulatory standards and Astellas SOPs and are executed on time. Ensures viable strategies are established for regulatory applications.
* Collaborates with GRA management to provide oversight on regulatory matters; and where needed, directs the contributions to meetings with regulatory authorities and similar experts and bodies.
* Guides Extended GRA team members, Regional Regulatory Leads or other GRA staff in a matrix organization on regulatory and decision-making issues. Shares relevant information and drives development of viable strategies and/or methodologies which reflect up-to-date regulatory and compliance standards. Identifies and escalates where appropriate to resolve significant issues and risks.
* Provides regulatory expertise for planning, approving regulatory content.
* Monitors regulatory developments, guidelines, and industry trends, particularly with respect to assigned projects/products, and contributes to the preparation of recommendations and robust opinions for management in a timely manner.
* Interprets, identifies, recommends, and advises project/program teams and Company on regulatory guidelines and risk matters and is accountable for the development and implementation of plans to address regulatory and/or product issues.
* May provide regulatory advice to ad hoc teams/task forces set up for process improvements, alignment with new regulatory requirements or business initiatives on behalf of GRA.
* Contributes to the strategy for interaction with Health Authorities or business partners for the assigned projects/products. Builds and maintains good relationships with Regulatory Authorities.
Organization & People Management
* Supports an environment to enable each member of the Regulatory Affairs team to optimally operate in the matrix environment of GRA, Global Medical Development, Technology/PPM and Astellas (e,g, GMS, regional commercial businesses, Medical Affairs, Legal, affiliates, etc).
* Represents GRA within project/product teams and collaborates with global Astellas stakeholders to affect global strategies and consistency in regulatory messaging.
$88k-125k yearly est. 60d+ ago
Trial Services Deputy Director - County Indigent Defense System
Dasstateoh
Regulatory agency director job in Columbus, OH
Trial Services Deputy Director - County Indigent Defense System (250006HU) Organization: Public Defender CommissionAgency Contact Name and Information: Josh Barton, ************************** Unposting Date: Feb 2, 2026, 4:59:00 AMPrimary Location: United States of America-OHIO-Franklin County-Columbus Compensation: $45,198 - $157,560Schedule: Full-time Classified Indicator: UnclassifiedUnion: Exempt from Union Primary Job Skill: Executive LeadershipTechnical Skills: Attorney/Legal, Executive LeadershipProfessional Skills: Building Trust, Coaching, Decision Making, Innovation, Negotiation, Strategic Thinking Agency OverviewThe Office of the Ohio Public Defender (OPD) is the state agency responsible for providing legal representation and other services to people accused or convicted of a crime who cannot afford to hire an attorney.Our Mission: Advocating. Fighting. Helping.Our Vision: A Fair Justice System.Our Values: Compassion. Dignity. Equity. Integrity. Service. Community.We are committed to building a work environment where all team members have a voice and can embrace our differences to innovate service to the public in our pursuit of fairness and justice for all people.Follow OPD on Facebook, LinkedIn, Instagram, and Threads | Visit our WebsiteJob DescriptionThe OPD is seeking a passionate, organized, and strategic indigent defense leader to join its executive leadership team as a Trial Services Deputy Director 4 responsible for supporting effective indigent defense delivery systems in counties throughout Ohio. You will directly negotiate with county commissioners to enact contracts for indigent defense services in their counties; work to recruit and support good government contracting processes; establish and build communications with judges and prosecutors; develop and implement new procedures; and supervise a team of three trial attorneys who are appointed to represent the most challenging cases in local systems where qualified attorneys are otherwise not available. You may also carry a small caseload.This position entails active, independent responsibility for building systems and processes. To be successful, you must have prior individual contributor or leadership experience in public defense and demonstrate the ability to build programs and innovate within complex systems to continually improve client service and reduce inequities. You will also serve in an advisory capacity to the Assistant Director of Trial Services, Assistant Director of Columbus Office, and the State Public Defender. Essential functions of the position include but aren't limited to:Multi-county program operations:Manage negotiations for indigent defense systems serving Adams, Athens, Brown, Fayette, Jackson, Pickaway, Pike, Ross, and Washington counties.Negotiate contract provisions with county officials and private attorneys.Work with external members of the justice system (e.g., judges and prosecutors), contract attorneys, and county commissioners.Recruit and place contract attorneys and monitor their compliance with all applicable ethical, professional, and legal obligations.Establish and sustain beneficial business relationships.Collaborate with agency training staff to formally assess and manage the professional development needs of contract counsel.Work with internal teams in Fiscal and Office Services and Legal Counsel in the review of agency personal service contracts for legal compliance and accepted contract principles.Assist with the assessment of current indigent defense systems: for example, review public defender offices and court-appointed counsel for legal compliance pursuant to Ohio Revised Code 120.04(B)(3) through conducting site visits; analyzing caseload and budget data; answering questions regarding Ohio Administrative Code; and recommending changes to agency standards and guidelines.Advisory capacity:Assist in the formulation of policies, procedures, and administrative rules; assist with formulating, implementing, and evaluating the agency budget; assist with the evaluation of proposed and recently enacted legislation affecting agency operations.Personnel management:Directly supervise attorneys: approve work schedules; respond to questions and concerns and resolve problems; disseminate and interpret policies and procedures and best practices; provide coaching and training, and complete timely performance reviews; succession planning and position reviews.Oversee budgets and financial resources in support of the division/agency strategic initiatives and mission (e.g., approve requests for training, travel, projects, and equipment).Special projects and other duties:Collaborate with leadership teams across the division and Columbus Office to develop onboarding and professional development programs for trial-level attorneys.Render legal advice to county public defenders and members of the private bar on all matters of criminal law and the provision of representation to indigent criminal defendants.Serve as an attorney-at-law to represent indigent criminal defendants in the courts across the state. May directly handle a reduced caseload; apply a high level of technical and legal skills to formulate innovative legal strategy that effectively and successfully represents indigent criminal defendants.This position requires in-office time and extensive travel in the State of Ohio as well as occasional travel outside Ohio. You will have an office location in our Columbus office.When you submit your application, please upload a Resume and a Cover Letter indicating how you are best qualified for this position and why you feel you are the best fit for the Ohio Public Defender's Office.This Trial Services Deputy Director position is assigned to the State of Ohio's E-2 Pay Range 44. Target compensation for this position is $137,000 to $145,000.The Office of the Ohio Public Defender complies with federal and state disability laws and makes reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, please contact HCM at ************ or ******************** Work for the State of OhioAt the State of Ohio, we take care of the team that cares for Ohioans. We provide a variety of quality, competitive benefits to eligible full-time and part-time employees*. For a list of all the State of Ohio Benefits, visit our Total Rewards website! Our benefits package includes:
Medical Coverage
Free Dental, Vision and Basic Life Insurance premiums after completion of eligibility period
Paid time off, including vacation, personal, sick leave and 11 paid holidays per year
Childbirth, Adoption, and Foster Care leave
Education and Development Opportunities (Employee Development Funds, Public Service Loan Forgiveness, and more)
Public Retirement Systems (such as OPERS, STRS, SERS, and HPRS) & Optional Deferred Compensation (Ohio Deferred Compensation)
*Benefits eligibility is dependent on a number of factors. The Agency Contact listed above will be able to provide specific benefits information for this position.QualificationsAdmission to Ohio Bar pursuant to Section 4705.01; 18 months exp. as licensed attorney practicing criminal law; 6 mos. exp. or 6 mos. trg in supervisory principles & techniques.Job Skills: Executive Leadership; Attorney/Legal; Strategic Thinking; Building Trust; Decision Making; Innovation; Negotiation; Coaching.Supplemental InformationIntentional omission of relevant information, falsification, or misrepresentation of information on the application will disqualify the applicant. In addition, such intentional acts are grounds for immediate termination of an employee.Final candidates selected for this position will be required to undergo a drug test. An applicant with a positive test result will not be offered employment. Final candidates selected for this position will also be required to undergo a criminal background check and state income tax check. Criminal convictions do not necessarily preclude an applicant from consideration for a position. An individual assessment of an applicant's prior criminal convictions will be made before excluding an applicant from consideration. This position serves at the pleasure and discretion of the State Public Defender. This position serves in a fiduciary relationship to the State Public Defender and will have an unclassified status per Ohio Revised Code 124.11 (A) (9).ADA StatementOhio is a Disability Inclusion State and strives to be a model employer of individuals with disabilities. The State of Ohio is committed to providing access and inclusion and reasonable accommodation in its services, activities, programs and employment opportunities in accordance with the Americans with Disabilities Act (ADA) and other applicable laws.Drug-Free WorkplaceThe State of Ohio is a drug-free workplace which prohibits the use of marijuana (recreational marijuana/non-medical cannabis). Please note, this position may be subject to additional restrictions pursuant to the State of Ohio Drug-Free Workplace Policy (HR-39), and as outlined in the posting.
$137k-145k yearly Auto-Apply 4h ago
Temp to Perm - Remote Opportunity - Regulatory Affairs Manager
Collabera 4.5
Remote regulatory agency director job
Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30+ offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services. We provide services to Fortune 500 and mid-size companies to meet their talent needs with high quality IT resources through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs.
Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence.
Job Description
Required: (Remote Opportunity - Temp to Perm)
• The Regulatory Affairs Manager ensures compliance to FDA and other applicable regulations.
• In this role, you will lead the preparation, analysis, and submissions dossiers to various governing agencies in supporting business growth.
• The RA Manager supports compliance with applicable regulations including ISO, local, state, and/or federal requirements.
• Preparing international regulatory submissions and FDA submissions which may include device 510(k), IDEs, PMAs) and serving as regulatory representative on selected project teams; developing departmental SOPs/policies regarding regulatory matters.
Key responsibilities:
• Lead Regulatory Associates or Specialists in addition to work as an individual contributor
• Prepare, review and file FDA premarket submission to ensure devices are commercially available in the U.S.: pre-IDEs, IDEs, 510(k)s, PMAs and PMA Supplements. (Will also be involved in EU submissions)
• Represent RA as core team member to drive innovation on Tech. Dev. Projects and follow through to market release.
• Develop Regulatory Strategies for new or modified products and prepare project plans & budgets.
• Monitor and provide management with impact of changes in the Regulatory environment.
• Communicate with regulatory agencies on administrative and routine matters in addition to pre-clinical, pre-submission, and submission discussions under the direction of management.
• Document, consolidate and maintain oral and written communication with FDA, notified bodies, and clinical investigators.
• Support Design Control process.
• Prepare Rational to file documentation for modifications to devices when appropriate.
• Participate in FDA & other notified body Inspections.
• Author and/or review regulatory procedures and update as necessary.
• Review change control documents and ascertain Regulatory impact for external and internal documents.
• Assist in development/maintenance of regulatory files, records and reporting systems of systematic retrieval of information.
• Review promotional material and labeling for regulatory compliance.
Qualifications
Required qualifications:(Remote Opportunity)
• Bachelor's degree required. Scientific or engineering field preferred.
•
5+ years of medical device regulatory affairs experience.
• Must have authored 510(k) submissions
• Must have knowledge of U.S. FDA regulations and standards
• 3+ years of experience interacting with FDA and/or other regulatory agencies
• Experience with devices containing software is strongly preferred.
• Must work well in team environments
• Must demonstrate leadership skills in team setting.
• Proven analytical abilities
• Solid understanding of manufacturing and change control, and an awareness of regulatory trends
Additional Information
To know more on this position or to schedule an interview, please contact;
Ujjwal Mane
************
ujjwal.mane[@]collabera.com
$111k-151k yearly est. 3d ago
Deputy Director Of Development
Voter Gravity 3.4
Remote regulatory agency director job
Job Title: Deputy Director of Development Department: Development Reports to: Reports to Chief Executive Officer Classification: Permanent Remote Pay Range: $80,000 - $100,000 Hours: Full Time (40 hours/week)
Job Summary:
A Healthier Democracy (AHD) is seeking a Deputy Director of Development to manage fundraising operations for A Healthier Democracy and its initiatives, Vot-ER and Link Health. The Deputy Director will report to the CEO and work in deep collaboration with the Executive Directors of the two priority initiatives.
A Healthier Democracy builds platforms for collaboration and community organizing at the intersection of health and civic engagement to maximize collective impact on pressing challenges.
A Healthier Democracy is home to high-impact national initiatives. We believe our nation's biggest and most complex challenges require innovative solutions leveraging healthcare settings and healthcare workers. Our centralized model enables us to quickly launch new initiatives drawing on deep expertise in healthcare organizing, creative communications, and marketing.
Key initiatives include:
Vot-ER is working to integrate nonpartisan civic engagement into healthcare. Vot-ER develops nonpartisan civic engagement tools and programs for every corner of the healthcare system-from private practitioners to medical schools to hospitals. It transforms routine healthcare visits into opportunities for civic empowerment, partnering with trusted health professionals, and reaching historically underrepresented communities.
Link Health is dedicated to empowering individuals and communities by facilitating enrollment in vital public benefit programs. Link Health uses AI to strategically address the immediate needs of individuals by connecting them to essential financial assistance for rent, healthy food, utilities, and internet subsidies while they wait in healthcare settings. Its mission is to ensure equitable access to resources for healthcare, energy assistance, nutrition support, and more, fostering healthier and more resilient communities.
Duties/Responsibilities:
Provide project management of donor cultivation and engagement activities, including events, briefings, webinars, etc (both virtual and in person).
Manage relationships with existing donors for both maintenance (renewals) and growth opportunities.
With CEO and initiative Executive Directors, identify and facilitate connections to priority prospects.
Maintain a regular system of contact with donors across all giving levels and priority prospects.
Develop and update fundraising messaging and materials.
Manage daily activities of the development office.
Drive the execution of a strategic, creative fundraising plan, primarily focused on institutional and individual major donors.
With the CEO, develop partnerships with allied organizations and identify creative intersections for alignment.
Provide direct support to the CEO and manage his outreach and relationships.
Provide leadership and guidance to the initiative Executive Directors, directing where and how best to spend time and efforts.
Partner with the CEO and initiative Executive Directors to identify, cultivate and solicit institutional and individual donors for major gifts.
Provide support to the CEO and initiative Executive Directors for all aspects of their fundraising activities/responsibilities.
Collaborate with CEO initiative Executive Directors in developing fundraising micro-strategies and donor engagement plans.
Coach development staff.
Oversee maintenance of the donor database and internal systems.
Oversee the grant writing process, including editing and project management
Review grant proposals and reports prior to submission; ensure timely submission.
Ensure fundraising strategies, donor communications, and engagement practices reflect the organization's commitment to DEI.
Analyze donor data, giving trends, and campaign outcomes to inform strategic decision-making and identify growth opportunities.
Develop and implement robust donor acknowledgment, recognition, and retention strategies to build long-term relationships and increase loyalty.
Required Skills/Abilities:
Demonstrated commitment to racial equity and inclusion.
Demonstrated ability to work collaboratively to gain trust and give respect to others through honesty, integrity, kindness, empathy, and authenticity.
Acute attention to detail and demonstrated ability to prioritize time to meet deadlines for multiple projects.
Drive to seek what can be improved and offer ways to fix any potential roadblocks.
Comfort admitting what you don't know and recognizing that feedback is part of the learning process.
A strong commitment to A Healthier Democracy, Vot-ER, and Link Health's missions.
Demonstrated success in project management, and people management.
Experience with donor cultivation and management.
Demonstrated success in supporting principals in their development activities.
Track record of meeting fundraising goals and budgets.
Outstanding attention to detail.
Excellent analytical, oral communication, teamwork and people skills.
Demonstrated flexibility and openness in responding to changing work priorities.
Education and Experience:
5-7 years of work experience, preferably for a nonprofit or advocacy organization.
Experience in a fundraising role preferred
Physical Requirements:
Prolonged periods of sitting or standing at a desk and working at a computer.
Ability to lift a minimum of 20 pounds.
Other Requirements:
Ability to travel a minimum of four times per year.
$80k-100k yearly Auto-Apply 10d ago
Compliance Lead, Regulatory Compliance
EQT 4.6
Remote regulatory agency director job
EQT is one of the United States' leading producers of natural gas and the first traditional energy company of scale in the world to achieve Net Zero on a Scope 1 and Scope 2 basis.
From the office to the field, the #EQTeam is fueling the future. Power your potential with us.
At EQT, we are making strides toward becoming the best producer by creating long-term value for all stakeholders, including employees, landowners, communities, industry partners and investors. Our vision is to evolve EQT into a modern, connected, digitally enabled organization.
With an incredibly collaborative culture and a determined, progressive workplace, EQT was both named a National Top Workplace, as well as one of Pittsburgh's Best Places to Work!
Join our Qrew!
The Compliance Lead, Regulatory Compliance supports EQT's enterprise compliance framework by leading execution of key regulatory compliance activities throughout the organization. This role coordinates regulatory tracking, impact assessment, and change management efforts, ensuring that new or evolving requirements are efficiently assessed, communicated, and integrated into business operations.
Working cross-functionally with Legal, Operations, Upstream, Midstream, Environmental, and Safety teams, this position helps drive consistency, strengthen controls, and reinforce a culture of proactive compliance across the organization.
The Compliance Lead, Regulatory Compliance responsibilities include but are not limited to:
Maintain EQT's regulatory repository and compliance control documentation to ensure requirements remain current, traceable, and actionable.
Track and assess regulatory developments affecting upstream and midstream operations, as well as the domestic and international supply of natural gas to customers.
Lead the regulatory impact assessment process, coordinating input from business stakeholders to evaluate applicability and operational impact.
Partner with compliance champions and process owners to embed regulatory obligations into procedures, training, and monitoring activities.
Support the development and execution of remediation and control improvement plans for identified compliance risks or findings.
Analyze preventable notices of violation (NOVs) and similar enforcement actions to identify root causes and drive sustainable corrective actions.
Coordinate compliance change management activities, ensuring updates to requirements are communicated, documented, and operationalized.
Provide data-driven insights to inform compliance reporting, audits, and management reviews.
Contribute to continuous improvement initiatives by identifying efficiency opportunities in compliance monitoring, documentation, and reporting.
Required Experience and Skills:
Bachelor's degree in law, engineering, environmental science, business, or a related discipline.
7-10 years of progressive regulatory compliance experience in the natural gas, midstream, or broader energy sector.
Proven ability to interpret, implement, and operationalize requirements from agencies such as FERC, PHMSA, EPA, OSHA, and state-level regulators.
Experience maintaining compliance repositories, impact assessments, or control frameworks.
Strong analytical and problem-solving skills, with the ability to assess regulatory risk and drive remediation activities.
Excellent communication and collaboration skills; able to influence and coordinate across diverse teams and functional areas.
Demonstrated integrity, judgment, and discretion when managing sensitive or confidential information.
Skilled in managing multiple priorities and adapting to a dynamic regulatory environment.
Proficiency with GRC platforms, data analytics, or regulatory tracking systems preferred.
Preferred Experience and Skills:
Advanced degree (JD, MBA, or master's) or professional certification (CCEP, CRCM, CPCU, CAMS).
Experience supporting or enhancing compliance management systems and regulatory reporting tools.
Strong understanding of regulatory frameworks and enforcement practices relevant to the natural gas industry.
Prior experience coordinating compliance change management or regulatory implementation projects.
Effective at developing presentations and reports for business and regulatory audiences.
Ability to mentor junior compliance staff or serve as a subject matter resource within the compliance program.
Remote work is being considered for this role excluding the following states: California, Connecticut, Delaware, Illinois, Indiana, Louisiana, Massachusetts, Michigan, New Jersey, New York, and Tennessee unless willing to relocate.
Selected incumbent will be placed into the position that best suits their abilities and experience level.
EQT Corporation and its subsidiaries is an Equal Opportunity Employer -- Disabilities/Veterans.
$89k-123k yearly est. Auto-Apply 59d ago
Regulatory Affairs Senior Director - Global Regulatory Leader - Obesity
Amgen 4.8
Remote regulatory agency director job
Career CategoryRegulatoryJob Description
HOW MIGHT YOU DEFY IMAGINATION?
You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Regulatory Affairs Senior Director - Global Regulatory Leader - Obesity
Live
What you will do
Let's do this. Let's change the world. In this vital role you will support products in the Obesity Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules.
To lead GRTs within Amgen's GRAAS organization
To independently develop a comprehensive regulatory strategy for one or more high complexity programs, typically in late-stage development and/or with multiple indications, that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions
To provide Regulatory leadership to cross-functional teams for high complexity programs with major Regulatory deliverables such as global original marketing applications
Develop and implement global regulatory product strategies designed to achieve approval and target product labeling for prioritized assets in late development with highly complex development programs
Represent GRA on the product team and other key commercialization governance bodies, guide and influence the organization to achieve Regulatory objectives
Independently develop the Global Regulatory Strategic Plan and provide regulatory input into the product's Global Strategic Plan. Obtain input from the GRT members to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance. Identify and communicate regulatory risks
Provide regulatory direction in the development of the core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance, and precedent
Independently lead the planning and implementation of global regulatory filings (eg, clinical trial applications, marketing applications, label extensions)
Ensure consistency of evidence-based global product communication (eg, regulatory submission documents)
Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment; advise product teams and GRT on implications of pertinent changes
Assess regulatory mechanisms to optimize product development (eg, expediting FIH studies, Orphan Drug Designation, Fast Track Designation, conditional /accelerated approval, compassionate use, and pediatric plan) and ensure appropriate incorporation into the global regulatory strategy
Clearly and succinctly communicate regulatory strategies, associated risks, mitigations, and contingencies to the organization such that the probability of regulatory success and potential outcomes are well understood
Lead GRTs and product teams in formal and informal communications with regulatory agencies
Lead the approach and strategy for formal interactions with Regulatory agencies, especially those which could impact the global product strategy
Represent Amgen Regulatory on external partnership teams at the product level
Lead regulatory process improvements and initiatives
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
Basic Qualifications:
Doctorate degree and 5 years of regulatory experience in biotech or science
OR
Master's degree and 8 years of regulatory experience in biotech or science
OR
Bachelor's degree and 10 years of regulatory experience in biotech or science
Preferred Qualifications:
Contemporary obesity experience desired
Demonstrated ability to lead regulatory aspects of highly complex programs in late development
Previous experience leading a Regulatory team for submission and approval of an original marketing application and/or major new indication supplemental application
Ability to lead and build effective teams
Strong communication skills - both oral and written
Ability to understand and communicate scientific/clinical information
Ability to anticipate and mitigate against future strategic issues and uncertainties
Ability to resolve conflicts and develop a course of action
Cultural awareness and sensitivity to achieve global results
Planning and organizing abilities
Able to prioritize and manage multiple activities
Ability to make complex decisions and solve problems
Ability to deal with ambiguity
Organizational savvy
Negotiation skills
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.
Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
#Obesity
.
Salary Range
216,805.00 USD - 259,624.00 USD
$100k-131k yearly est. Auto-Apply 60d+ ago
Deputy Director
Licking County, Oh 3.6
Regulatory agency director job in Heath, OH
Deputy Director Division: Homeland Security/E.M.A./911 Contact Name: Tammy Smoke, SHRM-CP, PHR Contact Email: [email protected] Contact Phone: ************ Contact Fax: ************ Date Posted: 11/14/2025 Position Location: 783 Irving Wick Drive West, Heath, Ohio 43056 Position Description:
Duties:
* Demonstrates regular and predictable attendance.
* Promotes and maintains positive and effective working relationships and promotes good public relationships as a representative of Licking County Government.
* Assigns work and evaluates employee performance; receives and resolves employee issues according to established guidelines; approves timesheets and leave requests; schedules shifts and ensures coverage for call offs; recommends and/or issues corrective action as necessary. Participates in interviewing and makes recommendations for hiring of employees in conjunction with the 911 Coordinator and EMA Director. Actively involved in employee and/or labor relations and contract negotiations.
* Ensures that the 911 Coordinator is in compliance with state and federal rules for PSAP operations.
* Point of contact for employees call-offs for the specific shift that is being supervised. Coordinates filling shifts and ensures it is filled.
* Develops and manages the 911 Center budgets. Monitors Expenditures.
* Recommends contracts and agreements to the EMA Director in relation to the 911 Center.
* Oversees, maintains and updates a variety of dispatch records as required; Ensures current licensures for the department are in compliance with Federal Communications Commission (FCC) regulations.
* Develops short- and long-term plans and strategies for Enhanced 911 and communications.Promote awareness among the citizens of the district as to the use of the 911 emergency telephone system. Coordinates with all law enforcement, fire and medical agencies in all matters pertaining to the 911emergency telephone system, and provides periodic informational updates to all local jurisdictions and local agencies.
* Oversees, monitors and maintains a variety of dispatch equipment including computer-aided dispatch (CAD) system, automated telephone system, and radio system; works with other County/City staff and outside agencies to ensure systems are working properly. Monitors new developments within the communications industry and recommends updates to the system as enhancements are developed.
* Researches, investigates and resolves inquiries, concerns and complaints sensitive in nature.
* Assesses needs and makes recommendations for training to Shift Supervisor/Training and QA and assists in the development of training.
* Acts as the liaison between the 911 Center and County/City Fire, EMA and related personnel on technical issues.
* Researches, investigates and resolves inquiries, concerns and complaints. Keeps 911 Coordinator advised as necessary.
* Acts as departmental designee for Public Record Requests.
* In emergency situations may back up 911 dispatchers. May be assigned EMA duties during planned or unplanned events.
* Meets all job safety requirements and all applicable PERRP safety standards that pertain to the essential functions of the position and all agency safety procedures.
* Remains informed of current developments and procedures pertinent to duties; may be required to attend seminars/training.
Program: 911 Operations Brief Description:
Manages and oversees the day to day operations of the Licking County Regional Communications Center (LCRCC)/911 Center. Ensures the County is in compliance with all federal, state, and local laws pertaining to the LCRCC. Identifies areas of improvement and implements changes to be in compliance with federal, state and local laws.
Job Prerequisites:
Minimum Qualifications:
Bachelor's Degree from a four-year college or university; and three (3) to five (5) years related experience and/or training; a minimum of two (2) years supervisory experience; or equivalent combination of education and experience.
Additional Qualifications (Agency/Dept. Qualifications):
Management experience in a dynamic environment.
Prior Dispatch experience preferred.
Leadership.
Organizational ability.
Proficiency in Microsoft Word, Excel and other related software.
Computer Aided Dispatch Systems*
Consoles and tone boards and paging systems*
Minor computer programming is essential.
Effective written and oral communication skills.
Contributes to building a positive team environment and applies conflict resolution skills as necessary.
Possesses excellent interpersonal and multi-tasking skills.
Ability to manage a fast pace, potentially stressful environment.
Ability to be covered under the county fleet vehicle liability insurance policy.
Ability to obtain and maintain certifications listed below.
CERTIFICATES, LICENSES, REGISTRATIONS
Law Enforcement Automated Data System (LEADS) Certified (must acquire within 30 days of hire)
CPR, PRO-QA, EMD, EPD & EFD Certification*
FEMA IS100, 200, 300, 400, 700 & 800
FEMA Professional Development Series & Advanced Professional Development Series (APS)*
Emergency Numbers Professional (preferred)
Valid Ohio Driver's License
* may be acquired after hire and within six (6) months of employment
may be acquired after hire and within one (1) year of employment
* may be acquired after hire and within two (2) years of employment
Application Procedure:
Submit completed application, resume and cover letter to the Licking County Human Resources Department, 20 South Second Street, 3rd Floor, Newark, Ohio 43055. Applications can be obtained in person in the Human Resources Department between 8:00 a.m. and 4:30 p.m. daily or printed from the web site at ********************** Applications can be submitted directly online or e-mailed to [email protected] or faxed to ************.
Compensation:
Salary: $90K+ based on experience
About UFA:
Licking County is an Equal Opportunity Employer.
Job Type: Full Time Pay Type: Salary
$90k yearly 60d+ ago
CEN State Affiliate Director
CCV 4.3
Regulatory agency director job in Columbus, OH
The Christian Education Network (CEN) State Affiliate Director is responsible for overseeing the expansion of state partnerships, creation of a marketing strategy for network growth, developing school partnerships, providing accountability to state affiliates, and creating strategies for expanding the national scholarship granting organization (SGO) network.
Reports to: CEN Executive Director
Hours: Monday-Friday, 8:00am to 4:30pm
Compensation: Full-time, Salaried/Exempt
Location: CCV Office in Columbus, Ohio, with Occasional Statewide Travel
Benefits: PTO (Paid Time Off), 10 Paid Holidays, Monthly Cell Phone Allotment, Mileage, Health, Vision, and Dental Insurance (CCV covers 75% of premium), Life Insurance, 3% Match on Retirement Plan Available after 1 Year
Key Responsibilities
Support the growth and expansion of CEN affiliate networks across the country.
Cooperate with CEN Director to identify, onboard, and support state affiliate networks.
Create systems for developing state networks, providing guidance for establishing state-level goals related to policy advocacy, SGO growth, and school planting.
Provide accountability for meeting all state-level goals.
Assist states with implementing the CEN SGO marketing strategy.
Provide the CEN board of directors with all requested reports. Implement any policies or actions given by the board.
Prepare an annual report to stakeholders.
Other duties as assigned.
Job Qualifications & Requirements
Skills and Experience
Undergraduate degree required.
3-5+ years of Christian school leadership or other managerial experience.
Ability to create and implement systems that will spur growth and effectiveness of each state affiliate.
Proficiency managing databases and producing accurate reports.
Effective written and oral communicator.
Ability to create and meet deadlines.
Character and Spiritual
Mature Christian, currently attending or pursuing attendance in a local church.
Agreement with and adherence to CCV's Statement of Faith and Code of Conduct.
Demonstrated commitment to CCV's mission and position on Core Issues.
Ability to work discreetly with confidential information.
Trustworthy, responsible, tactful, diplomatic, and focused on building consensus rather than emphasizing differences.
Maintain a high level of professionalism focused on client/constituent relationships.