Regulatory process manager jobs near me - 48 jobs

Join Our Visionary Team within Regulatory and Change Management Governance (RCMG) - Disclosure Center of Excellence (DCOE)! RCMG Vision: We revolutionize change management with a process-centric approach, streamlining workflows and enhancing reporting tools for maximum efficiency. Our aim is to facilitate seamless transitions and effective regulatory change management, making it effortless for all stakeholders. Disclosure COE Focus: Step into the Disclosure COE, where you'll access a centralized library of standardized, reusable customer-facing disclosures. We ensure consistency, mitigate regulatory risk, and boost efficiency for businesses communicating these disclosures. Supporting key sectors, we cover all products and communication channels for comprehensive customer engagement. Why Join Us? As a new joiner, you'll be part of a dynamic team committed to excellence in communication and regulatory management. You'll play a crucial role in documenting essential disclosures in our Golden Source Disclosure Library, shaping how we interact with customers and uphold our regulatory commitments. Join us in our mission to transform change management and disclosures, making a significant impact on our business and stakeholders. Be a catalyst for positive change and innovation! We are seeking a motivated, tech-savvy Data Analyst with a strong background in data analysis and business processes to join our DCOE team. Job responsibilities This role has primary accountability for analyzing and interpreting complex data sets to identify trends and patterns that can drive business decisions. Collaborate with cross-functional teams to understand business requirements and translate them into technical specifications. Continuously seek opportunities to enhance existing processes and systems, ensuring alignment with business goals. Communicate findings and recommendations effectively to stakeholders at all levels. Stay updated with emerging technologies and industry trends to ensure the organization remains at the forefront of innovation. Conduct Data Discovery & data analysis to provide business insights and stories to various stakeholders Devise improvements to current procedures and develop methods for increasing efficiency, accuracy, and performance of data quality solutions Required qualifications, capabilities, and skills Curious and motivated to learn and enhance processes. Proficiency in Excel, including advanced functions, pivot tables, and data analysis etc. Experience with Excel VBA programming and automation Strong communication skills and the ability to distill complex concepts to a variety of audiences and levels - including to senior management, project contributors, technical and business facing partners. Strong organizational and time management skills, and ability to multi-task and manage multiple priorities independently. Initiative-taking, energetic, results-oriented, curious and attention to detail. Exhibits a continuous improvement mindset towards all duties. Skilled in multitasking for timely, high-quality results. Works well independently in fast-paced environments. Preferred qualifications, capabilities and skills Domain Knowledge in Corporate Bank Lending, Financial Services Operations Experience in Python for writing scripts for ETL tasks and Experience in migrating data workflows on-premises to public cloud (AWS) Experience working with various databases (Teradata, Oracle), Snowflake, AWS, data lake querying engines with modern cloud-based data architectures Experience with business intelligence and data analytics tools (Alteryx, Tableau, Business Objects, QlikSense)

Clorox is the place that's committed to growth - for our people and our brands. Guided by our purpose and values, and with people at the center of everything we do, we believe every one of us can make a positive impact on consumers, communities, and teammates. Join our team. #CloroxIsThePlace Your role at Clorox: The Director of Government Affairs will be responsible for providing strategic leadership and directional oversight of the enterprise-wide Government Affairs function for Clorox, a public consumer packaged goods company. In close collaboration with the Sustainability, Strategic Regulatory, and Legal teams, the successful individual will be responsible for building relationships with key stakeholders and shaping the regulatory landscape to advance the company's strategic business objectives. The Director of Government Affairs will play a critical role in developing and executing an enterprise advocacy strategy, including establishing a strong presence in Washington, D.C., managing relationships with key trade associations, overseeing political contributions, and tracking relevant legislation. The role will also focus on building influence in key federal districts and managing state and local issues related to the company's manufacturing facilities and offices. Reporting to the Vice President, Enterprise Risk Management and Government Affairs, this individual will be a dynamic leader with a passion for driving strategic influence, fostering a culture of collaboration, and effectively communicating opportunities and risks to internal and external stakeholders. In this role, you will: Lead the development and execution of a comprehensive government affairs strategy that establishes a strong presence in Washington, D.C., builds a reputation with Congress and the executive branch, and advances the company's strategic business objectives. Additionally, refine and help guide the External Affairs approach in international markets in which the Company operates. Develop and lead initiatives to connect executive stakeholders with relevant Members of Congress, fostering relationships and driving influence in key federal districts based on manufacturing locations and corporate interests. Work collaboratively with a team of government relations professionals, fostering a culture of accountability, collaboration, and continuous learning while ensuring alignment with functional and corporate business needs. Represent the company in external forums and engage with internal and external stakeholders, including trade associations, industry forums, and government officials, representing the Company's interests and commitment to responsible corporate citizenship. Manage relationships with enterprise trade associations, providing support and coordinating with key executive stakeholders. Oversee political contributions and ensure compliance with reporting requirements. Jointly develop the advocacy strategies with Business Units and the Strategic Regulatory team, aligning efforts to maximize impact. Track relevant pending legislation in close coordination with the Strategic Regulatory team, ensuring organization awareness of key issues and adjusting advocacy strategy as necessary. Develop and implement robust processes to manage state and local issues relative to manufacturing facilities and offices. Serve as a champion of government affairs, building relationships and effectively communicating enterprise-level priorities and risks to cross functional teams, ensuring government affairs considerations are integrated into business strategies and decision-making processes. Oversee and manage lobbying resources to ensure effective representation of the company's interests. What we look for: Bachelor's degree required, degree in political science, public policy, or related field. At least 8 years' experience in government affairs and legislative and regulatory processes at the federal and/or state level. Must also have experience in the CPG (consumer-packaged goods) industry with a strong network in Washington, D.C. Be able to effectively navigate complex political landscapes, drive organizational influence, and elevate the strategic importance of government affairs within the company. Have demonstrated experience in leading government affairs strategies, building relationships with key stakeholders, and managing political contributions. Must be a proven, effective communicator with the capability to advocate the company's interests and drive alignment across diverse audiences within the organization. Be able to set strategy, contributing to the creation and articulation of an inspiring vision for the organization's government affairs function and its broader impact on the enterprise. Have a collaborative and creative approach to developing advocacy strategies that support company strategies. The ability to set clear and challenging goals while committing the organization to improved influence and performance; tenacious and accountable in driving results. The ability to persevere in the face of challenges and exhibit a steadfast resolve to higher standards, effectively navigating ambiguity and complexity to solve critical issues impacting the business. Be able to attract and recruit top talent, motivate the team, delegate effectively, and manage performance. Encourage collaboration and visibly support the success of the team, creating a sense of purpose that engages others. Naturally connects and builds strong relationships with government officials, trade associations, and internal stakeholders, demonstrating high emotional intelligence and strong communication skills. Workplace type: Hybrid: This role will work onsite 3 days a week at a designated location in DC. The other two days will be remote. Our values-based culture connects to our purpose and empowers people to be their best, professionally and personally. We serve a diverse consumer base which is why we believe teams that reflect our consumers bring fresh perspectives, drive innovation, and help us stay attuned to the world around us. That's why we foster an inclusive culture where every person can feel respected, valued, and fully able to participate, and ultimately able to thrive. Learn more. [U.S.]Additional Information: At Clorox, we champion people to be well and thrive, starting with our own people. To help make this possible, we offer comprehensive, competitive benefits that prioritize all aspects of wellbeing and provide flexibility for our teammates' unique needs. This includes robust health plans, a market-leading 401(k) program with a company match, flexible time off benefits (including half-day summer Fridays depending on location), inclusive fertility/adoption benefits, and more. We are committed to fair and equitable pay and are transparent with current and future teammates about our full salary ranges. We use broad salary ranges that reflect the competitive market for similar jobs, provide sufficient opportunity for growth as you gain experience and expand responsibilities, while also allowing for differentiation based on performance. Based on the breadth of our ranges, most new hires will start at Clorox in the first half of the applicable range. Your starting pay will depend on job-related factors, including relevant skills, knowledge, experience and location. The applicable salary range for every role in the U.S. is based on your work location and is aligned to one of three zones according to the cost of labor in your area. -Zone A: $175,100 - $360,700 -Zone B: $160,500 - $330,700 -Zone C: $145,900 - $300,600 All ranges are subject to change in the future. Your recruiter can share more about the specific salary range for your location during the hiring process. This job is also eligible for participation in Clorox's incentive plans, subject to the terms of the applicable plan documents and policies. Please apply directly to our job postings and do not submit your resume to any person via text message. Clorox does not conduct text-based interviews and encourages you to be cautious of anyone posing as a Clorox recruiter via unsolicited texts during these uncertain times. To all recruitment agencies: Clorox (and its brand families) does not accept agency resumes. Please do not forward resumes to Clorox employees, including any members of our leadership team. Clorox is not responsible for any fees related to unsolicited resumes.

At Neumora, we are pushing the boundaries of science and technology to revolutionize the way patients with brain disease are treated. We are seeking extraordinary individuals to join our team as we grow and advance our pipeline. We are seeking a highly motivated Director, Regulatory Affairs, reporting to the VP of Regulatory Affairs, who will lead and oversee development plans incorporating regulatory strategies designed to maximize chances of successful and expedient registration for assigned programs. The Director will represent Regulatory Affairs in multi-disciplinary teams to establish development and regulatory strategies for early through late-stage development programs. Responsibilities: Independently serve as the regulatory representative on cross-functional teams. Communicate regulatory strategies and risk assessments to cross-functional teams and senior leadership, as needed. Collaborate with Clinical Development, Clinical Operations, CMC, QA/QC, Nonclinical, Program Management, and external consultants to align regulatory results and ensure strategic integration of regulatory considerations into program plans. Independently lead the central messaging, preparation, and submission of high-quality, regulatory-complaint regulatory dossiers. Proactively communicate issues, outcomes, and risks to the VP of Regulatory Affairs and relevant teams. Provide regulatory review of documentation prepared by other technical functions supporting product development activities (e.g., clinical protocols, clinical study reports, statistical analysis plans, etc.) in accordance with regulatory guidelines/requirements. Provide leadership and management for the coordination and preparation of submissions consistent with regulatory requirements and in accordance with corporate strategy and timelines. Ensure accuracy and consistency of regulatory submissions and correspondence. Handle vendor/consultant roles, where applicable. Serve as the regulatory point of contact for interactions with FDA and other global health authorities. Critically review nonclinical and clinical trial-related documentation (e.g., protocols, informed consents, clinical study reports) for compliance with regulatory guidance. Provide regulatory strategic guidance on documents and submission plans to align with study and company objectives. Interact directly with regulatory agencies; manage agency interactions. Ensure submissions to regulatory health authorities are complete, organized, of high quality, and compliant with applicable regional regulations. May assist with due diligence to support business development opportunities. Provide leadership within the Regulatory department, identifying and managing through completion departmental and cross-project initiatives and regulatory obligations. Qualifications: B.S./M.S. degree in a scientific discipline or related field. Minimum of 10 years of Pharmaceutical Regulatory Affairs experience; experience in neuropsychiatric indications preferred. Thorough knowledge of the drug development process, drug laws, and global regulations and requirements is required. Experience supporting development stage programs (Phase 1-3). Experience with IND/CTA and license applications. Experience with management of commercial product(s) highly desirable. Ability to work in a hybrid environment and with distributed teams; startup/small company experience preferred. Self-starter who can independently lead assigned projects. Experience in central nervous system disease research a plus. Strong analytical skills, problem solving ability, and presentation skills. Excellent communication and interpersonal skills to enable engaging and influencing diverse stakeholders from a variety of professional backgrounds. 2026 Company benefits include: Medical, dental, vision, and life insurance 401(k) plan: Neumora matches 50% of an employee's eligible contribution, up to the first 6% of salary (up to 3% employer contribution) Company Equity (New Hire Awards, Annual Awards, ESPP) Annual paid time off: Accrued Vacation Days: 15 days per year Sick Days: 10 days per year Company Holidays: 13 days plus summer recharge week in July and winter shutdown in December Leave of Absence: Paid Medical Leave, Paid New Parent Bonding Leave, Paid Family Leave, paid short-term and long-term disability Discretionary year-end bonus The salary range posted describes the minimum to maximum base salary range for this position in the location listed. Actual salary may vary based upon geographic location, work experience, education, licensure requirements and/or skill level and will be finalized at the time of offer. Base Salary Range:$221,675 -$244,434 Neumora Therapeutics, Inc. is a clinical-stage biopharmaceutical company founded to confront the greatest medical challenges of our generation by taking a fundamentally different approach to the way treatments for brain diseases are developed. Our therapeutic pipeline currently consists of seven programs that target novel mechanisms of action for a broad range of underserved, prevalent diseases. Neumora's mission is to redefine neuroscience drug development by bringing forward the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients. Neumora is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless. If this sounds like you, keep reading! Role Summary The Director, CMC and Device Regulatory Affairs will lead the implementation of global regulatory CMC strategies for drug-device combination products (e.g., prefilled syringes and autoinjectors) across all phases of development through licensure, ensuring compliance with global regulatory requirements. The role requires a strong understanding of regulatory CMC aspects for biologics and/or drug-delivery combination products. This functions as a strategic partner, contributing to strategy development, leading key initiatives, and supporting broader regulatory objectives. Key Responsibilities Develop and implement global CMC and device regulatory strategies for assigned program(s) Lead the preparation and review of CMC and device regulatory submissions (e.g., INDs, CTAs, BLAs, MAAs, Notified Body submissions) Collaborate with Technical Operations, Quality, Clinical, and Regulatory teams to ensure regulatory requirements are integrated into product development plans Identify regulatory risks associated with product development and propose mitigation strategies Manage interactions with regulatory agencies and notified bodies, including meeting preparation and responses to queries Review CMC-related changes for potential impact on global submissions, provide regulatory impact assessments, and work with project teams to ensure timely reporting of changes Archive and maintain regulatory submissions and correspondences in Apogee's regulatory information management system Contribute to the optimization and implementation of processes and procedures, commensurate with departmental and company growth Ideal Candidate Advanced degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field Minimum of 10 years of industry experience, with at least 6 years in CMC regulatory for biologics and/or drug-delivery combination products Experience with late-stage development (Phase 3) and/or BLA/MAA/Notified Body submissions preferred Proven track record of leading cross-functional submission teams and successful regulatory submissions Strong knowledge of global regulatory requirements (FDA, EMA, ICH) Excellent communication, leadership, and project management skills Detail-oriented with ability and desire to work in a fast-paced, nimble, hands-on, team-oriented, biotech environment Up to 15 - 20% travel is required, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year Successfully exhibit Apogee's C.O.R.E. values: Caring, Original, Resilient, and Egoless The anticipated salary range for candidates for this role will be $220,000-$240,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. A pogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. To review our privacy policy, click here It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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.

Maserati produces a complete range of unique cars with an amazing personality, immediately recognizable anywhere. With their style, technology and innately exclusive character, they delight the most discerning, demanding tastes and have always been a global automotive industry benchmark. A tradition of successful cars, each of them redefining what makes an Italian sports car in terms of design, performance, comfort, elegance and safety, currently available on more than 70 markets internationally. The role of TSRC Manager will be responsible for overseeing the compliance-related activities concerning the business perimeter of Maserati Americas, in coordination with Maserati HQ, Stellantis N.A. TSRC, S.E. Tech Center, CCLP teams. This Leader will be the Official Maserati representative (with power of attorney) with Agencies & Trade Associations and support in key Maserati governance (e.g. RTM) and coordination/approval meetings. Key Responsibilities Interface with federal, province, and state agencies on regulatory policy and compliance. Support technical committees at the Alliance for Automotive Innovators in U.S. and Global Automakers in Canada in coordination with Stellantis' TSRC. Assemble “Maserati-specific” concerns on major North American rulemakings and coordinate with Stellantis' TSRC on their potential inclusion in formal Stellantis responses Submit all safety related reports to federal, province, and state agencies. Manage safety recall process for US and Canada. Manage new model year CPCR process with Maserati S.p.A. and FCA US TSRC. Review Owner's manual & Warranty Books. Approve Safety, Emissions, and other Homologation Labels for each model year. Manage FMVSS and CMVSS phase in plans in cooperation with Maserati S.p.A. and FCA US TSRC. Oversee, manage, and execute integrated plans for certification of Maserati products (planning & execution phases) Validate certification applications and fleet reporting for submission to agencies In order achieve certification for each model year, work must be done to define emissions test groups, evaporative test groups, durability groups, OBD groups, and Fuel Economy Groups; lead emissions, fuel economy, and OBD certification activities; interface with Maserati engineering to plan and execute emissions certification testing; gather the required information and submit certification applications including emission test results to EPA and CARB; submit OBD certification documents and DDV test results to CARB; support confirmatory testing as required at EPA laboratory; request EPA certificate and CARB executive orders Troubleshooting and escalation for certification & campaigns Assess Regulation to provide recommendations for portfolio, product & development planning Explore opportunities for exemptions, derogations, optimization of phase-in plans Support Maserati commercial & marketing teams in product communication & dealer training Support Maserati SCM on compliance implications linked to product labeling and logistic flows Budgeting for compliance activities and control of administrative obligations, including submitting payment of emission certification fees to EPA and CARB. Prepare and present the annual emissions certification preview to EPA and CARB. Review, approve, and submit to EPA and CARB all emissions related running change and field fix documents Manage activities relating to emissions related parts and defect reporting Serve as the authorized signer for official documents submitted to agencies on behalf of Maserati US LLC Prepare and submit required importation documents for Canada.

The Task At Hand: Shape the rules. Unlock new markets. Drive the future of THC beverages. JuneShine Brands is building an innovative social tonic platform, with Willie's Remedy+ leading the next wave of THC beverages. As one of the fastest-growing brands in the category, we're entering a critical growth phase where regulatory leadership and advocacy will define who wins. As the Director of Regulatory Affairs, you'll serve as our in-house expert on hemp beverage regulation - anticipating where state and federal rules are going, influencing outcomes, and guiding our expansion into new markets. From market access to packaging and DTC considerations, you'll turn regulatory complexity into a competitive advantage. This is a high-impact, externally facing role reporting to the CFO and working closely with the CEO, Board, and industry partners to advance advocacy efforts and unlock scalable growth. If you thrive in ambiguity, enjoy shaping emerging policy, and want to help define a fast-moving category, this role is for you! Who You Are: Strategic regulatory and government affairs leader navigating complex state hemp laws Deep expertise in hemp and cannabis beverage regulations with a business-first mindset Hands-on, entrepreneurial operator comfortable owning regulatory strategy, advocacy and compliance oversight Thrives in ambiguous, rapidly evolving regulatory environments Relationship builder with regulators, policymakers, and industry partners Effective collaborator with leadership, and cross functional teams What You'll Do: Regulatory Strategy & Advocacy: Critical Focus: Anticipate and help shape hemp beverage regulations, with particular emphasis on packaging formats, DTC considerations and market access Represent Willie's in state-level advocacy efforts, industry coalitions and working groups Build and maintain relationships with state regulators, policymakers, and key industry associations Develop and deliver regulatory positions, comments, and advocacy materials to influence outcomes in priority markets Identify and pursue opportunities to proactively influence regulatory direction before rules are finalized Educate external stakeholders on hemp beverage safety, consumer benefits and responsible regulation Hemp State Regulatory Oversight & Market Enablement: Serve as the primary internal expert on state hemp beverage regulations across all active and expansion markets Monitor evolving state regulatory frameworks and advise leadership on business implications and strategic tradeoffs Support market entry and expansion strategies based on state-specific regulatory requirements Partner with internal teams to ensure alignment across formulation, labeling, marketing, and go-to-market execution Stay ahead of enforcement trends through ongoing engagement with state regulatory agencies Compliance Leadership & Team Development: Lead and develop the compliance function as Willie's Remedy+ scales nationally Set compliance strategy, priorities and operating rhythm to support multi-state growth Ensure the team has the resources, guidance, and clarity needed to executive effectively Must Haves: 21 years of age or older at the time of application 5-8+ years of experience in regulatory or government affairs within hemp, cannabis, adult beverage, or other highly regulated CPG categories Deep knowledge of state-level hemp beverage regulations, including market access and packaging considerations Proven experience engaging with or influencing state regulators, policymakers, or industry groups Ability to translate complex regulatory requirements into clear, actionable business guidance Experience partnering with executive leadership to inform strategic and commercial decisions Experience leading or mentoring regulatory or compliance professionals Ability to support key markets (preference for CA, TX, or DC) and travel as needed Nice to Haves: JD or formal legal training Existing relationships with regulators or industry advocacy groups Experience supporting market expansion or retail enablement Familiarity with FDA, TTB, or state beverage control agencies Exposure to DTC or e-commerce in regulated categories Experience building or scaling compliance or regulatory functions within a growing organization Entrepreneurial mindset with comfort operating in fast-moving, ambiguous environments Compensation, Perks + Benefits: Compensation: $150,000 - $160,000 per year The final offer will be based on several factors, including experience, skills, and overall expertise Equity Eligible Perks + Benefits: Unlimited Paid Time Off Healthcare coverage: up to 90% company contribution for employees and 25% for dependents Voluntary vision, dental, and accidental plans 401(k) with up to 4% company match 12 weeks of paid Equal Parental Leave, $500 Baby Bonding Bucks, and a sustainable baby gift Booch, spirit, beer, and soft good perks And more! Who We Are Our Purpose: To make quality, purpose-driven beverages Our Business: Our vision is to create the next-generation beverage platform, comprising distinct brands, each with its own ethos and purpose. Despite being a multi-billion dollar industry, it lacks options that cater to the next generation of drinkers who will demand more from their alcohol than a mere buzz. Disrupting this industry is a worthy, and massive opportunity. Our Culture: Our core values are Quality, Transparency, and Team-First. We derive much of our management policy from a book we give you upon hiring, ‘Let My People Go Surfing', by Yvon Chouinard (founder, owner, Patagonia). Our policy is to allow workers flexible hours, provided the work gets done with no negative impact on others. Our ‘let my people go surfing' policy demands that we hire very unique individuals; those with a combination of self-motivation, self-discipline, and energy. JuneShine Brands is a purpose-driven organization composed of a diverse and dynamic group of individuals with varied backgrounds, passions, and beliefs. We are committed to fostering an inclusive environment where everyone's unique perspectives are valued. We seek to hire self-motivated, independent thinkers, who embrace challenging the status quo. Join us at JuneShine Brands where you're encouraged to bring your authentic self to your craft every day. As a proud equal opportunity employer, we are dedicated to ensuring fairness and equity in our hiring practices. You must reside in the United States to be considered for this position. This role supports multiple beverage brands within the JuneShine Brands portfolio, including alcohol and hemp-derived THC beverages.All Juneshine Brands products are intended for adults 21+. ©2025 Juneshine Brands| ***************** | ******************** | ******************** | Please enjoy responsibly. All rights reserved.

About the Company Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address unmet patient needs. Powered by its proprietary DPL platform, composed of NEObody, SAFEbody, and POWERbody technologies, Adagene's highly differentiated pipeline features novel immunotherapy programs. Adagene has forged strategic collaborations with reputable global partners that leverage its technology in multiple approaches at the vanguard of science. Job Summary The Head of Global Regulatory Affairs is a key leadership position that will oversee and is accountable for global regulatory, quality strategies and policies for Adagene. This individual will be responsible for regulatory leadership and oversight to help develop global regulatory and quality compliance strategies, and guidance. As a Head of Global Regulatory Affairs this person will perform a critical role in strategies, documentations, submissions, and company interactions to regulatory authorities such as FDA, CFDA, and other regulatory agencies. This individual must leverage their extensive experience to represent Adagene in regulatory affairs in discussions with internal and external stakeholders. This role will provide global regulatory expertise and contribute to the delivery of the Clinical, R&D and Operations strategies. This individual will lead cross-functional and multicultural team and diverse environment. The candidate must have an entrepreneurial mindset, highly motivated and purpose driven leader who is able to flexibly and effectively lead and interact with multi-disciplinary teams. This individual should have experience in championing new ideas in a dynamic, international, and innovative environment. The successful candidate will have a track record of accomplishments in global regulatory affairs, project management, strong collaboration, and communication skills. This position may require travelling to our company headquarters in Suzhou, China. Essential Functions Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Serve as a key member of senior management team to provide leadership and guidance to ensure business objectives are aligned with company strategies and achieve operational objectives to gain product approvals. Provide counseling, training, and interpretation of FDA, CDE and other regulatory requirements to all company personnel. Lead, coach, and mentor the Regulatory departments and ensuring appropriate levels of accountability for decision making and clearly communicate cross-functionally within the organization. Oversee preparation and filing of all regulatory documents with the FDA, CDE and other regulatory agencies. Develop and maintain external relationships with key opinion leaders and regulatory officials. Direct the development of systems, practices, and processes to ensure effective ongoing review of clinical development plan, product design and/or manufacturing changes and adverse events. Provide leadership and direction for significant deviation events that may impact compliance status or represent the significant business risk. Responsible for company's product quality and reliability to meet or exceed regulatory. Lead company's Quality Compliance to ensure compliance with regulatory agencies and all applicable standards. Develop and execute quality design and quality assurance strategy for new product development and sustaining business activities. Support the quality system, provide effective leadership support, training, and guidance to all company personnel. Serve as the ambassador to and develop strategies for responses to regulatory related inquiries from global regulatory agencies and ensure issues are addressed in a timely manner. Responsible for leading all regulatory activities for assigned projects in line with regulatory requirements, regional requirements and scientific and company policies and procedures. Provide regulatory oversight and strategic and technical guidance in discussions with teams in support of due diligence for potential in-licensing activities, external collaborations, and acquisitions. Lead Global Regulatory efforts for all INDs, NDAs, and life cycle management. Maintain knowledge of highly complex regulatory requirements up to current date, while influencing preparation of new regulatory guidance wherever possible. Champion initiatives that contribute to global process improvements, which have a significant impact on business. Direct activities of Contract Manufacturing Organizations (CMOs) and Contract Research Organization's (CRO's), material suppliers, consultants, and vendors. Other projects or responsibilities as may be required. Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions of the job. Minimum Qualifications - Education and Experience A PharmD or PhD degree in a scientific discipline and a minimum of 10 years of pharmaceutical and drug development regulatory experience, as well as a background in dealing with the FDA and international regulatory agencies is required for this position. Minimum 10-15 years of progressively responsible Regulatory experience in a pharmaceutical, biotechnology or related environment. Position also requires a minimum of 5-8 years of leadership experience in a global regulatory affairs role. Must have extensive knowledge of regulatory requirements, including ICH GCP, GMP, GLP, and regional requirements and understand current global and regional trends in regulatory affairs and the ability to assess the impact of these requirements to the business. Extensive knowledge of clinical development, FDA and international global clinical trial regulations and ICH GCP GMP, CLP guidelines and relevant requirements Substantial experience in all aspects of regulatory affairs, including Clinical, Commercial support, CMC, with a track record of successful submissions and license approvals with CDER and CBER Demonstrated global leadership capability, ideally gained through regulatory leadership of multiple global development programs and NDA/MAA submissions. Excellent working knowledge of the US, European and Asian regulations for drugs and biologics. Knowledge of global regulatory guidance as they relate to the overall global regulatory strategy. Must be able to travel (US/international) up to 25%. Preferred Qualifications - Education and Experience RAC Certification preferred Equal Opportunity Employer Adagene is an equal opportunity employer that is committed to diversity and inclusion. We prohibit discrimination and harassment of any kind based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, pregnancy, veteran status, or other legally protected characteristics as outlined by federal, state, or local laws. Learn more about your EEO Rights as an applicant. Adagene will not discriminate or retaliate against applicants who inquire about, disclose, or discuss their compensation. Adagene will consider for employment all qualified applicants with criminal histories in a manner consistent with applicable law. If you are applying for a position in San Francisco, review the San Francisco Fair Chance Ordinance guidelines applicable in your area. Adagene participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program. Adagene is committed to working with and providing reasonable accommodation to applicants with physical and mental disabilities. Adagene is a drug-free workplace.

Job Description About Immuneering: Immuneering is a clinical-stage oncology company outpacing cancer to help patients outlive their disease. Our lead product candidate, atebimetinib (IMM-1-104) is currently in a Phase 2a trial in patients with advanced solid tumors including pancreatic cancer. Immuneering's R&D team is based in a ~38,000 square foot lab and office facility in San Diego. The company also has offices in New York City and Cambridge MA. Immuneering has grown to more than 50+ employees, all working to apply their expertise, passion and creativity to improve the lives of people with serious diseases. Immuneering's team works collaboratively and relentlessly, thinking across traditional boundaries to help shape the frontiers of drug development. General Summary of Duties: The Director, Regulatory, CMC (Chemistry, Manufacturing, and Controls) is a pivotal regulatory role responsible for developing and executing regulatory strategies for CMC activities across the company's clinical product portfolio. This position ensures compliance with all applicable regulatory requirements and works cross-functionally to support product development, registration, and lifecycle management. A successful candidate will be a highly collaborative individual with strong interpersonal skills and will be an exceptional team player. Specific Duties, may include but not be limited to the following: · Develop and lead global CMC regulatory strategies for investigational and commercial products to ensure timely submissions and approvals. · Prepare, review, and submit CMC sections of regulatory documents including INDs, IMPDs, NDAs, BLAs, ANDAs, and supplements to FDA, and other regulatory authorities including the EMA. · Provide regulatory guidance on CMC matters to project teams, including manufacturing changes, process development, and technology transfers. · Monitor and interpret current and emerging CMC regulatory requirements, guidelines, and trends to proactively address potential impacts. · Represent Regulatory CMC in cross-functional teams and meetings, providing expertise and input on regulatory implications of manufacturing and quality changes. · Lead interactions and communications with regulatory agencies regarding CMC topics, e.g. pre-IND, end-of-phase, and pre-submission meetings. · Work with a sense of purpose to get work done using influence and good project management skills, fostering alignment with organizational goals. · Collaborate with Quality, CMC, R&D, Finance, Legal, Clinical and other internal departments to ensure regulatory compliance and readiness. Partner effectively and smoothly with CRO's and consultants. Desired Skills and Qualifications · Bachelor's degree in Chemistry, Pharmacy, Life Sciences, or related field required; advanced degree (PhD, PharmD, MS) highly preferred. · Minimum of 8+ years of experience in CMC regulatory affairs within the biopharmaceutical or pharmaceutical industry, including experience with small molecule development in oncology. More experience is a plus. · Proven track record of successful CMC submissions and approvals in the US and internationally. · In-depth knowledge of FDA, EMA, and ICH guidelines, regulations, and processes related to CMC. · Strong leadership, communication, and project management skills. · Must be focused on working collaboratively and within our values of: Data rules, All-in, Own it (Accountable), Caring and Humble. · Ability to work effectively in a collaborative, fast-paced environment. Location: Remote or Hybrid, if you live near an Immuneering office, regular Meet Ups are available. Physical Demands/ Working Conditions The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires the ability to perform essential job functions with or without reasonable accommodation. No significant lifting is associated with the role. While extensive travel is not anticipated with this role, it is possible to perhaps up to [X]% at times. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role. Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission. Job Offers: Immuneering uses the Immuneering.com domain and email addresses for all official communications. If you received communication from any other domain, please consider it spam. Note to Recruitment Agencies: We appreciate your interest in finding talent for Immuneering but please be advised that we do not accept unsolicited resumes from recruitment agencies. All resumes submitted to Immuneering without a prior written agreement in place will be considered property of Immuneering, and no fee will be paid in the event of a hire. Thank you for your understanding.

Blockchain.com is connecting the world to the future of finance. As the most trusted and fastest-growing global crypto company, it helps millions of people worldwide safely access cryptocurrency. Since its inception in 2011, Blockchain.com has earned the trust of over 90 million wallet holders and more than 40 million verified users, facilitating over $1 trillion in crypto transactions. As the US Regulatory Compliance Manager, you will be the architect and leader of our US regulatory strategy. This is a cornerstone position responsible for navigating the complex federal and state regulatory landscape to enable our continued growth and innovation. You will own the company's licensing roadmap, serve as the primary relationship manager with regulators, and provide strategic guidance that embeds compliance into the fabric of our products and operations. Your work will be critical to securing the company's long-term success and trustworthiness in the market. WHAT YOU WILL DO Regulatory Strategy & Leadership: Develop, implement, and manage the company's comprehensive US regulatory compliance program. Licensing Execution: Spearhead the company's state-by-state licensing strategy, with a primary focus on obtaining and maintaining Money Transmitter Licenses (MTLs). This includes managing applications, renewals, surety bonds, and required reporting across all relevant jurisdictions. Regulatory Engagement: Serve as the primary point of contact and cultivate strong, proactive relationships with federal and state regulators, including FinCEN, OCC, and state banking departments. Manage all regulatory examinations, inquiries, and correspondence. Product Compliance Advisory: Partner directly with Product, Engineering, and Business leadership to provide proactive regulatory guidance on new products and initiatives. Ensure a “compliance-by-design” approach, translating complex regulatory requirements into actionable product specifications. Reporting: Provide regular, clear reporting on the status of the compliance program, risk exposure, and key regulatory developments to the executive team. WHAT YOU WILL NEED 7 years of regulatory compliance experience within the financial services or fintech industry. Demonstrated, hands-on experience with the US Money Transmitter Licensing (MTL) framework, including application, maintenance, and reporting processes. Deep subject matter expertise in BSA/AML, KYC/CIP, and OFAC sanctions programs. Proven ability to interpret and apply complex financial regulations to innovative products and business models. What we'd love to see (Preferred Qualifications): Juris Doctor (J.D.) or a relevant advanced degree (e.g., MBA). Direct experience with cryptocurrency or digital asset compliance programs. Experience in a high-growth technology company environment. Established relationships and direct interaction experience with key state and federal financial regulators. Professional certifications such as CAMS (Certified Anti-Money Laundering Specialist) or CRCM (Certified Regulatory Compliance Manager). COMPENSATION & PERKS Competitive full-time salary based on experience and meaningful equity in an industry-leading company This is a role based in our Dallas office, with a mandatory in-office presence four days per week. The opportunity to be a key player and build your career at a rapidly expanding, global technology company in an exciting, emerging industry. Performance-based bonuses Apple equipment provided by the company Work from Anywhere Policy: You can work remotely from anywhere in the world for up to 20 days per year. Blockchain is committed to diversity and inclusion in the workplace and is proud to be an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, religion, color, national origin, gender, gender expression, sex, sexual orientation, age, marital status, veteran status, disability status or any other characteristic protected by law. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, and apprenticeship. Blockchain makes hiring decisions based solely on qualifications, merit, and business needs at the time. You may contact our Data Protection Officer by email at ******************. Your personal data will be processed for the purposes of managing Controller's recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of Regulation (EU) 2016/679 (General Data Protection Regulation) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller's behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. Because the European Union Commission has determined that United States data privacy laws do not ensure an adequate level of protection for personal data collected from EU data subjects, the transfer will be subject to appropriate additional safeguards under the standard contractual clauses. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability. In addition, you may lodge a complaint with an EU supervisory authority.

at Moneycorp Welcome to Moneycorp We're delighted you're interested in being a part of Moneycorp. In the last decade, Moneycorp has transformed from a largely domestic, consumer-focused provider of foreign exchange to an end-to-end global payments' ecosystem. With two banking licenses and operations across the entire value chain of the international payments and foreign exchange sectors, we enable businesses, institutions, and individuals to thrive beyond borders. We help our clients realise their growth ambitions by providing them with worldwide reach, relentless regulatory excellence, and tailored, relevant solutions that resiliently optimise their financial operations. We're fervent about pursuing our goals, making substantial contributions to the payments industry, and consistently offering unwavering support to our clients at every stage of their journey. Moneycorp is a place where energy, commitment to our shared success and collaboration are core to our DNA. We're restless in our drive to surpass the expectations of our clients and unlock opportunities to support them at every stage of their journey. The foundation of our success is our people, and nurturing a culture of belonging for all of our colleagues is central to our journey as a global business. Find out more about Moneycorp's offering, global footprint and capabilities here: About Us | moneycorp Who You Are / Your Next Challenge Moneycorp in Dublin have an exciting opportunity for an EMI (Electronic Money Institution) Regulatory Compliance Manager. The successful candidate will be responsible for supporting the Head of Compliance to ensure effective compliance frameworks are in place which aims to ensure compliance with regulatory requirements and with the conditions of the firm's regulatory authorisations. What we're looking for / Skills that will help you in the role Critical experience required: Experience working in payments/electronic money regulated firms Extensive knowledge and understanding of the applicable EU and CBI regulations Experience/knowledge of outsourcing and operational resilience regulations is required Knowledge and/or experience of DORA would be advantageous Critical skills required: Strong management skills Excellent communication skills, both written and oral Demonstrable track record in regulatory relationship management and compliance framework development Organisational and prioritisation skills Hard working, conscientious and trustworthy Accepts accountability for delivering results against deadlines Problem solver This position is full-time, permanent. The role is expected to be office-based in Dublin, Ireland. What you get in return:This role offers a competitive salary with bonus, plus a comprehensive benefits package. Interested?If the role sounds like you, we invite you to upload a copy of your CV by clicking on the Apply button. Start Date: ASAP Fostering a culture of belonging and inclusivity We're committed to creating a workplace where every individual feels valued, respected, and included. As an Equal Opportunity Employer, we actively cultivate an inclusive culture where diversity thrives, and we empower our colleagues to drive meaningful change within our organisation through initiatives like our DE&I focus groups and value champion network. Like many of our peers, we recognise that fostering inclusivity is an ongoing journey, and we remain steadfast in our commitment to progress. By measuring our efforts through regular assessments and listening to the feedback of our employees, we strive to ensure that our initiatives are impactful and responsive to the evolving needs of our workforce.Together, we want to build a workplace where everyone can bring their authentic selves to work, as we believe this is the foundation of innovation, creativity, and collective success. Connect with us For company news, announcements and market insights, visit our News Hub. You can also find Moneycorp on Facebook, Twitter UK, Twitter Americas, Instagram, LinkedIn, where you can discover how we are leading the way in global payments and currency risk management.

Maserati produces a complete range of unique cars with an amazing personality, immediately recognizable anywhere. With their style, technology and innately exclusive character, they delight the most discerning, demanding tastes and have always been a global automotive industry benchmark. A tradition of successful cars, each of them redefining what makes an Italian sports car in terms of design, performance, comfort, elegance and safety, currently available on more than 70 markets internationally. The role of TSRC Manager will be responsible for overseeing the compliance-related activities concerning the business perimeter of Maserati Americas, in coordination with Maserati HQ, Stellantis N.A. TSRC, S.E. Tech Center, CCLP teams. This Leader will be the Official Maserati representative (with power of attorney) with Agencies & Trade Associations and support in key Maserati governance (e.g. RTM) and coordination/approval meetings. Key Responsibilities Interface with federal, province, and state agencies on regulatory policy and compliance. Support technical committees at the Alliance for Automotive Innovators in U.S. and Global Automakers in Canada in coordination with Stellantis' TSRC. Assemble “Maserati-specific” concerns on major North American rulemakings and coordinate with Stellantis' TSRC on their potential inclusion in formal Stellantis responses Submit all safety related reports to federal, province, and state agencies. Manage safety recall process for US and Canada. Manage new model year CPCR process with Maserati S.p.A. and FCA US TSRC. Review Owner's manual & Warranty Books. Approve Safety, Emissions, and other Homologation Labels for each model year. Manage FMVSS and CMVSS phase in plans in cooperation with Maserati S.p.A. and FCA US TSRC. Oversee, manage, and execute integrated plans for certification of Maserati products (planning & execution phases) Validate certification applications and fleet reporting for submission to agencies In order achieve certification for each model year, work must be done to define emissions test groups, evaporative test groups, durability groups, OBD groups, and Fuel Economy Groups; lead emissions, fuel economy, and OBD certification activities; interface with Maserati engineering to plan and execute emissions certification testing; gather the required information and submit certification applications including emission test results to EPA and CARB; submit OBD certification documents and DDV test results to CARB; support confirmatory testing as required at EPA laboratory; request EPA certificate and CARB executive orders Troubleshooting and escalation for certification & campaigns Assess Regulation to provide recommendations for portfolio, product & development planning Explore opportunities for exemptions, derogations, optimization of phase-in plans Support Maserati commercial & marketing teams in product communication & dealer training Support Maserati SCM on compliance implications linked to product labeling and logistic flows Budgeting for compliance activities and control of administrative obligations, including submitting payment of emission certification fees to EPA and CARB. Prepare and present the annual emissions certification preview to EPA and CARB. Review, approve, and submit to EPA and CARB all emissions related running change and field fix documents Manage activities relating to emissions related parts and defect reporting Serve as the authorized signer for official documents submitted to agencies on behalf of Maserati US LLC Prepare and submit required importation documents for Canada.

At Anchorage Digital, we are building the world's most advanced digital asset platform for institutions to participate in crypto. Anchorage Digital is a crypto platform that enables institutions to participate in digital assets through custody, staking, trading, governance, settlement, and the industry's leading security infrastructure. Home to Anchorage Digital Bank N.A., the first federally chartered crypto bank in the U.S., Anchorage Digital also serves institutions through Anchorage Digital Singapore, Porto by Anchorage Digital, and other offerings. The company is funded by leading institutions including Andreessen Horowitz, GIC, Goldman Sachs, KKR, and Visa, with its Series D valuation over $3 billion. Founded in 2017 in San Francisco, California, Anchorage Digital has offices in New York, New York; Porto, Portugal; Singapore; and Sioux Falls, South Dakota. Learn more at anchorage.com, on X @Anchorage, and on LinkedIn. We're building something truly unique here at Anchorage Digital. As the only federally chartered digital asset bank in the United States, we sit at the intersection of traditional banking and the rapidly evolving world of digital assets. Our transaction monitoring team plays a critical role in that mission: protecting the integrity of the financial system while supporting innovation in a space that's redefining how money moves. Joining our team means being part of a first-of-its-kind institution where your work will directly shape the standards for compliance and risk management in digital finance. You'll collaborate with experts across banking, technology, and crypto to design and refine monitoring strategies that go beyond the playbook of traditional financial institutions. Every decision you help make has real impact. Not just for our clients, but for the broader industry. If you're looking for an opportunity to be on the cutting edge, to bring creativity and rigor to solving complex problems, and to help set the tone for how digital assets and banking coexist responsibly, this is the place to do it. We're not just monitoring transactions. We're helping write the future of finance Technical Skills: Demonstrates extensive knowledge and experience with the tools used by the transaction monitoring team, and is able to speak to them at a high level with senior management. Demonstrates experience in identifying gaps in team workflows and procedures, raising awareness to leadership with suggestions on how to properly address the gaps and ensure proper procedures are followed, updated, and training conducted within and outside of the team, as appropriate. Complexity and Impact of Work: Provide feedback to direct leadership on methods or systems used by the team, or outside of the team, having the ability to navigate roadblocks and obstacles that may come up, and escalating when blocked. Manage transaction monitoring alerts and disposition workflows. Ability to work independently with good time management skills, managing multiple tasks assigned with little to no direction, only requiring work to be reviewed at critical points. Ability to conduct Quality Assurance/Quality Check reviews of L1 Analyst reviews. Assist the team in tuning exercises, as well as implementation of monitoring rules to prevent and detect money laundering, fraud or other financial crime responding to emerging trends. Is a prolific contributor of high quality who makes impactful contributions to the team, and identifies opportunities for improvement. Consistently demonstrates on-time delivery and high quality work product. Where a deadline or commitment is at risk, escalates to manager to help manage priorities, if appropriate, and alerts affected stakeholders so "no surprises." Organizational Knowledge: Is aware of the strategy of Anchorage Digital to guarantee its successful implementation and is considered when defining the planning and goals of the team. Has a deep understanding of the team's objectives and works with leadership to ensure regulatory compliance is being met. Ensures that knowledge is shared amongst the transaction monitoring team and does not position themselves or others as a single point of failure. Communication and Influence: Promotes positive working environments for inside and outside of the team with proper listening, speaking and empathy with colleagues, as well as embodies as a role model of our culture pillars. Works closely with the team in order to solve problems and assist or guide other members in processes or workflows within their area of specialization or domain, helping others understand the strategic goals of Anchorage and how their work relates to these. Uses expert judgment, insight, recommendations, conclusion, and ideas on how to improve the team (e.g., workflows, inventory, etc.) Consistently expresses clear, thoughtful, analytical and solutions-oriented communications, whether in high-impact slides/decks, written communications in slack or email, or verbal communications. You may be a fit for this role if you have: Experience in BSA/AML transactional review for institutional and retail clients Knowledge in BSA/AML and/or Sanctions regulations + Fraud Typologies Expertise in using blockchain analytics tools to disposition transaction monitoring alerts, preferably at a Bank or regulated Exchange A passion for building out programs in their early stages, including creation and maintenance of policies, procedures, and new tools A proven track record of being able to work independently A strong attention to detail Highly curious and a fast learner Although not a requirement, bonus points if: You were emotionally moved by the soundtrack to Hamilton, which chronicles the founding of a new financial system. :) You have expertise in data analytics and/or spreadsheet pivots/formulas for data analysis Blockchain Analytics Certifications (TRM, Chainalysis, etc.) Fraud Certifications About Anchorage Digital: Who we are The Anchorage Village, what we call our team, brings together the brightest minds from platform security, financial services, and distributed ledger technology to provide the building blocks that empower institutions to safely participate in the evolving digital asset ecosystem. As a diverse team of more than 600 members, we are united in one common goal: building the future of finance by providing the foundation upon which value moves safely in the new global economy. Anchorage Digital is committed to being a welcoming and inclusive workplace for everyone, and we are intentional about making sure people feel respected, supported, and connected at work-regardless of who you are or where you come from. We value and celebrate our differences and we believe being open about who we are allows us to do the best work of our lives. Anchorage Digital is an Equal Opportunity Employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or veteran status. Anchorage Digital considers qualified applicants regardless of criminal histories, consistent with other legal requirements. “Anchorage Digital” refers to services that are offered either through Anchorage Digital Bank National Association, an OCC-chartered national trust bank, or Anchorage Lending CA, LLC a finance lender licensed by the California Department of Financial Protection and Innovation, License No. 60DBO-11976, or Anchorage Digital Singapore Pte Ltd, a Singapore private limited company, all wholly-owned subsidiaries of Anchor Labs, Inc., a Delaware corporation. Protecting your privacy rights is important to Anchorage Digital, and we work to maintain the trust and confidence of our clients when handling personal or financial information. Please see our privacy policy notices here.

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.

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

About Axiom: Axiom is transforming the legal services landscape by delivering innovative solutions ranging from individual secondees to fully integrated project teams that combine top-tier talent with cutting-edge technology. Join our innovative talent community and help drive impactful legal solutions to complex problems in various industries. Job Description: We are seeking a Regulatory Compliance Manager to join our Insurance Compliance team. This role is responsible for leading and managing regulatory compliance operations across assigned operating units, with a primary focus on Medicare Secondary Payer (MSP) compliance. The ideal candidate will bring deep experience in commercial insurance compliance, strong leadership capabilities, and the ability to collaborate across geographically dispersed teams in a fast-paced, enterprise environment. Responsibilities: Lead and oversee a sustainable, enterprise-wide Medicare Secondary Payer (MSP) compliance program, including: Evaluating and maintaining Medicare Responsible Reporting Entity (RRE) IDs Managing claims data collection and reporting across multiple claims systems Monitoring reporting accuracy, error rates, and corrective actions Implement and maintain processes for: Creation and ongoing management of RRE IDs Training, guidance, and oversight to ensure personnel awareness of MSP data collection and reporting requirements Ensure segment teams, operating units, and corporate leadership receive timely and accurate information regarding: Medicare reporting activities Compliance deficiencies Corrective action plans Monitor legal and regulatory developments related to MSP compliance and update the compliance program accordingly Conduct regular meetings with segment teams, operating unit personnel, and corporate leadership to: Maintain effective working relationships Assess program understanding Identify areas for improvement and implement action plans Effectively communicate new legislation and regulatory requirements impacting the business Collaborate on and support enterprise-wide initiatives related to in-scope compliance work Assist with other Corporate Compliance responsibilities as assigned Minimum Qualifications: Bachelor's degree required; Juris Doctor (JD) or equivalent strongly preferred 7+ years of commercial insurance experience 7+ years of compliance-related experience, including MSP compliance Demonstrated experience managing Medicare Secondary Payer compliance programs Ability to lead teams with varied backgrounds across multiple locations Strong analytical skills with the ability to exercise sound professional judgment Preferred Skills: Professional compliance or insurance-related designations Experience using legal and regulatory research platforms such as Westlaw, LexisNexis, or Wolters Kluwer Prior experience working in enterprise or multi-operating-unit environments Proficiency in Microsoft Office (Word, Excel, Outlook, Teams, SharePoint) Highly detail-oriented, organized, and able to meet time-sensitive deadlines Strong written and verbal communication skills Ability to work independently with minimal supervision Proven people-management and leadership skills Comfortable operating in project-based, fast-paced environments Willingness to travel occasionally as required Compensation, Benefits & Location: This role offers a range of competitive compensation starting at $130,000 and a highly competitive benefits package in the alternative legal services marketplace that includes health benefits, 401K and more. Axiomites also get access to professional development resources and learning and development programs. Axiomites predominately work remotely, with the exception that some clients require on-site presence. Axiom is the global leader in high-caliber, on-demand legal talent. Covering North America, the UK, Europe, and APAC, we enable legal departments to drive efficiency and growth and meet the demands of today's business landscape with best in breed alterative legal services. Axiom is a leader in diversity, inclusion, and social engagement. Diversity is core to our values and we are proud to be an equal opportunity employer. We are proud to be named a best place to work for LGBTQ+ Equality, earning top marks in the 2021 Corporate Equality Index for the second consecutive year. Axiom's legal department is Mansfield certified and is committed to considering at least 50% diverse candidates for leadership roles and outside counsel representation. Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. Learn more about working at Axiom. Equal Opportunity Employer: Axiom ensures equal employment opportunity in recruitment and employment, without discrimination or harassment on the basis of race, color, nationality, national or ethnic origin, religious creed or belief, political opinion, sex, gender reassignment, pregnancy or maternity, age, disability, alienage or citizenship status, marital (or civil or other partnership recognized by law) status, genetic predisposition or carrier status, sexual orientation, military service, or any other characteristic protected by applicable law. Axiom prohibits and will not tolerate any such discrimination or harassment. Accommodation for Individuals with Disabilities: Upon request and consistent with applicable laws, Axiom will provide reasonable accommodations for individuals with disabilities who require an accommodation to participate in each stage of the recruitment process. To request an accommodation to complete the application form, please contact us at ********************* and include "Applicant Accommodation" in the subject line. Axiom respects your privacy. For an explanation of the kind of information we collect about you and how it is used, our full privacy notice is available at **************************************** Employment with Axiom may be contingent upon successful completion of a background check, providing proof of identity, and possessing the necessary legal authorization to work. By submitting an application, you acknowledge that all information contained therein, and provided at any part of the application process, is correct and accurate to the best of your knowledge. #LI-AG1

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.

What Makes a Honda, is Who makes a Honda Honda has a clear vision for the future, and it's a joyful one. We are looking for individuals with the skills, courage, persistence, and dreams that will help us reach our future-focused goals. At our core is innovation. Honda is constantly innovating and developing solutions to drive our business with record success. We strive to be a company that serves as a source of “power” that supports people around the world who are trying to do things based on their own initiative and that helps people expand their own potential. To this end, Honda strives to realize “the joy and freedom of mobility” by developing new technologies and an innovative approach to achieve a “zero environmental footprint.” We are looking for qualified individuals with diverse backgrounds, experiences, continuous improvement values, and a strong work ethic to join our team. If your goals and values align with Honda's, we want you to join our team to Bring the Future! Job Purpose Leadership of process engineering through business plan development/implementation Oversee all aspects of process engineering and developing schedules to ensure adherence to deadlines and business goal achievement Department process engineer expert for MP (mass production) and New Model process efficiency and positive impact to business characteristics. Key Accountabilities Oversight of process engineering schedules and goal setting Data analysis for identification of improvement activities. Lead and Support department wide problem analysis and prevention activities for mass production process. AF (Assembly Frame) core systems expert (PDDA - process data development and analysis, EOS - electronic operations standards, &c) Train engineer and associates to manage changes. Deeply study process inefficiencies and promote characteristic improvements; apply and optimize change. Development of FSI (fundamental structural innovation) and BP (business plan) themes. Mentorship and development of succession planning. Reporting of BP status to upper management Workstyle This is a 100% onsite position, i.e. 5 days per workweek at job location. Visa sponsorship This position is not eligible for work visa sponsorship. Qualifications, Experience, and Skills Minimum Educational Qualifications: Bachelor s degree in engineering field or equivalent related experience. Minimum Experience: 8 or more years of demonstrable experience in production / lean manufacturing process design (e.g. - MOST) Automotive or transportation industry experience will be an asset. Other Job-Specific Skills: Strong continuous improvement (e.g. Kaizen) mindset, MOST etc. Strategies to design process with focus on improving manpower utilization efficiency MS Office365, MS Excel. Problem-solving / decision-making skills Project management capabilities. Theme development - be able to develop a business plan for KPI improvement Critical thinking skills What differentiates Honda and makes us an employer of choice? Total Rewards: Competitive Base Salary (pay will be based on several variables that include, but not limited to geographic location, work experience, etc.) Regional Bonus (when applicable) Manager Lease Car Program (No Cost - Car, Maintenance, and Insurance included) Industry-leading Benefit Plans (Medical, Dental, Vision, Rx) Paid time off, including vacation, holidays, shutdown Company Paid Short-Term and Long-Term Disability 401K Plan with company match + additional contribution Relocation assistance (if eligible) Career Growth: Advancement Opportunities Career Mobility Education Reimbursement for Continued learning Training and Development Programs Additional Offerings: Lifestyle Account Childcare Reimbursement Account Elder Care Support Tuition Assistance & Student Loan Repayment Wellbeing Program Community Service and Engagement Programs Product Programs Honda is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity and expression, age, disability, veteran status, or any other protected factor.

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