Regulatory affairs manager jobs near me - 151 jobs

A leading pharmaceutical company in San Diego is seeking a Regulatory Affairs Manager to oversee regulatory strategies for their development programs. You will work with cross-functional teams to ensure timely submissions and maintain regulatory compliance. The position requires a scientific degree and substantial experience in in relevant regulatory affairs. Benefits include competitive salary and health insurance. #J-18808-Ljbffr

A financial services company based in Palo Alto is looking for an experienced Associate General Counsel to support regulatory compliance and government relations. The successful candidate will have a J.D., be eligible for in-house practice, and possess 4-7 years of relevant experience. Responsibilities include managing regulatory frameworks, collaborating with legislative representatives, and advocating for consumer finance standards. This role is remote-first, allowing flexibility while contributing to a mission-driven culture. #J-18808-Ljbffr

SummaryThis role reports to the Global Head of Regulatory Affairs GE HealthCare's Pharmaceutical Diagnostics (PDx). This role provides strategic regulatory leadership for GE HealthCare's Pharmaceutical Diagnostics (PDx) business across the US and Canada. This role drives regulatory strategy for product development, submissions, approvals, and post-market compliance, ensuring alignment with business objectives and regulatory requirements. Acts as the primary liaison with FDA, Health Canada, and other authorities, influencing outcomes and accelerating time-to-market. GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.Job Description Key Responsibilities: Regulatory Strategy & Execution Develop and implement regional regulatory strategies to enable timely product approvals and lifecycle management. Interpret regulatory trends and business challenges to recommend best practices that enhance compliance and accelerate product development. Agency Engagement Lead interactions with FDA, Health Canada, and other regulatory bodies; manage negotiations and responses to agency queries. Represent GE HealthCare PDx in regulatory meetings and industry forums. Cross-Functional Leadership Collaborate with R&D, Manufacturing, Quality, Clinical, and the Commercial team to integrate regulatory requirements into development plans and commercialization strategies. Support the RA team providing regulatory guidance on labeling, advertising, and promotional materials. Team Leadership Lead and mentor a team of regulatory professionals; set priorities, allocate resources, and ensure timely, high-quality deliverables. Foster a culture of compliance, agility, and continuous improvement. Governance & Compliance Ensure adherence to FDA, Health Canada, and ICH guidelines; maintain compliance and registration dossiers. Drive initiatives to improve regulatory efficiency and proactively manage compliance risks. Business Support Participate in due diligence for product development, acquisitions, and in-licensing opportunities; assess regulatory risks and requirements. Support budget planning for the Regulatory Affairs function. Qualifications: Bachelor's degree in Life Sciences, Pharmacy, or related field; advanced degree preferred. 7+ years of regulatory affairs experience in the pharmaceutical industry, with proven leadership in US and Canadian markets. Expertise in regulatory pathways from IND through approval, launch, and lifecycle management; strong understanding of CMC, Quality, non-clinical, and clinical components. Experience leading meetings with FDA and Health Canada. Background in sterile injectables; radiopharmaceutical experience is a strong asset. Desired Characteristics: Strategic thinker with strong analytical and problem-solving skills. Excellent oral and written communication; ability to influence and negotiate effectively. Proven leadership and team development capabilities. Strong project management and organizational skills; ability to manage complex priorities. We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership -always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support. We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $180,000.00-$270,000.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.Additional Information GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. Relocation Assistance Provided: No Application Deadline: February 09, 2026

At Canopy Life Sciences, we are leading the way in advancing healthcare through innovation, collaboration, and a steadfast commitment to excellence. Our Regulatory Affairs division is made up of dedicated professionals who thrive in a dynamic, fast-paced environment, and we are seeking like-minded individuals to join our growing team. As an Associate Director to Director, Regulatory Affairs Advertising & Promotion, you will provide strategic, expert guidance on the advertising and promotion of assigned products, balancing regulatory requirements with the business needs and objectives of our clients. Your ability to anticipate challenges, offer innovative solutions, and foster strong relationships with both internal and external stakeholders will be key to your success in this role. This is a Remote position. Responsibilities include: · Act as the primary Regulatory expert within an assigned client's Medical, Legal, and Regulatory (MLR) team, providing balanced strategic counsel and tactical support on both commercial and development programs. · Conduct solutions-oriented and collaborative review and approval of all advertising and promotional materials, disease-awareness, scientific publications, training, and medical education materials and programs throughout an assigned product's lifecycle. · Maintain up-to-date knowledge of FDA laws, regulations and guidance documents, as well as the compliance environment as it relates to the advertising and promotion of pharmaceutical products and medical devices and advise teams as appropriate. · Support the review of proposed updates to package inserts/labeling, offering input on potential promotional messages and claims. Collaborate with teams to help integrate relevant labeling changes into product promotional materials as needed. · Support a variety of Regulatory Affairs initiatives within the Canopy Life Sciences Regulatory Affairs department related to ongoing process improvement, as assigned. Qualifications for this position include: · At least 5 years of pharmaceutical/medical device advertising and promotional regulatory review. · Ability to work independently in a remote role with minimal oversight.· Proven ability to manage multiple priorities simultaneously, maintaining focus and meeting deadlines in a fast-paced environment while balancing diverse tasks and responsibilities. · Strong team-oriented mindset with a collaborative attitude, able to work effectively with internal and external cross-functional teams to achieve common goals and drive successful outcomes. · Bachelor's degree (advanced degree in a science discipline preferred) As a part of our full-time team, you are eligible for our Comprehensive Benefits including: Medical, Dental and Vision Insurance Disability Insurance and Life Insurance 401(k) program with company match A balanced approach to work-life that offers a generous PTO program and Holidays. This is a remote position. Compensation: $170,000.00 - $210,000.00 per year We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. At Canopy, we help companies speed science from pipeline to people with end-to-end expertise and seamless support along the drug development journey. We provide both strategic and tactical solutions in the areas of MLR & Content Solutions, Medical Review, Medical Talent Solutions, Regulatory Affairs, Regulatory Operations, and Veeva Solutions. Together, we partner with our customers to deliver the on-demand expertise, technology, and service to catalyze their progress and get their product to the patients who need it, sooner. Our culture of one of empowerment, everyone in our company has a voice and plays a role in the success of the business and a role in developing our values and behavior. We recruit, train and develop people to ensure the very best for our client partners.

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. **Qualifications:** **Required** + Bachelor's degree in science required; Master's degree in science preferred + 5+ (e.g. 5-7) years in a discipline associated with pharmaceutical development or product oversight; 3 years in regulatory affairs preferred. + Strong scientific knowledge and regulatory experience applicable to the role. Solid basis in scientific approach, an ability to deal with technical information from a variety of disciplines + Good technical and regulatory knowledge of the requirements for compliance with GMPs, GLPs, GCPs and including knowledge of regulatory requirements and ICH guidance. + Proven track record of interaction with regulatory authorities. + Very good interpersonal, verbal and written communication skills with an ability to resolve conflict situations and influence regulatory authorities, as well as internal and external stakeholders. + Strong analytical and problem-solving skills + Good negotiation skills **Preferred:** + Experience participating in a multi-national environment + Proven track record in submissions and achieving approvals. + For roles within a GRA development TA, a track record in development and a foundation for global responsibilities in a development project including communication, alignment and success in association with regulatory strategies is preferred. **Salary Range** $122,500 - $192,500 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits:** + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program \#LI-SS Category Regulatory Strategy- Oncology Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

At Sirona Medical, we're building software that enables physicians to work as fast as they can think. Each year in the U.S., billions of patient images are captured-and nearly all of them are reviewed and diagnosed by radiologists. These specialists are the central hub of diagnostic medicine: over 80% of all healthcare data flows through radiology IT systems. Yet despite their pivotal role, radiologists are overburdened by outdated, fragmented software which limits their efficiency and ultimately the quality and efficiency of care that health systems can provide patients. That's where Sirona comes in. We're a San Francisco-based, cloud-native software company with employees around the world. Our deep understanding of both the practice and business of radiology has allowed us to build RadOS-a unified, AI-powered operating system powering the entire radiology workflows. How Sirona Solves the Problem Sirona is uniquely positioned to transform the way radiology is practiced. We're delivering the organizational shift that both individual radiologists and entire practices urgently need: A unified, intuitive, and platform-agnostic solution A streamlined workspace that makes every part of the radiologist's workflow faster and easier The freedom to read from anywhere, for anyone By cutting clicks, optimizing diagnostic time, and unlocking efficiencies that extend far beyond the reading room into all care settings, Sirona empowers radiologists-and in doing so, we help the entire healthcare system move faster, smarter, and with greater impact on patient outcomes. For more information, please visit ******************************** The Regulatory Affairs Manager (“RAM”) at Sirona will help build a comprehensive, global regulatory system, support teams in executing quality and regulatory guidance, identify and resolve regulatory-related issues, and drive continuous improvement. This individual will lead the execution of cross-functional regulatory initiatives and serve as a key representative and partner to the VP of Regulatory Affairs and Quality Assurance. Key Responsibilities: Partner with leadership and product managers to establish medical device classifications. Execute related plans to obtain required regulatory clearances or approvals in a timely manner Leverage external regulatory firms to design regulatory strategies and lead internal execution Determine regulatory requirements for selling and marketing Sirona medical devices globally, including local device classification, registrations, and in-country representation with appropriate partners Host audits and inspections conducted by U.S. and global regulatory agencies or standards bodies Collaborate cross-functionally to ensure regulatory requirements, concepts, processes, and objectives are clearly understood by all stakeholders Manage execution of regulatory affairs plans, including defining progress metrics and implementing escalation processes as needed Define and execute required regulatory certifications and MDSAP plans Host internal audits and regulatory inspections in partnership with the VP of RAQA Work closely with the engineering organization to establish, track, and continuously improve regulatory metrics Develop deeper regulatory and quality expertise through hands-on experience and mentorship Represent the VP of RAQA as needed, exercising sound judgment and decision-making (e.g., managing high-volume inquiries or operational decisions) Maintain a global regulatory watch and advise the business accordingly Key Requirements: 7+ years of medical device regulatory experience, preferably in software or technology-driven environments Working knowledge of FDA medical device regulations (Class I and/or II), EU MDR, and global regulatory standards, including ISO 13485 Strong organizational and communication skills, with the ability to produce clear, concise, and well-maintained documentation Experience conducting internal audits or supporting audit activities Experience hosting audits and regulatory inspections Ability to write, edit, and improve quality and regulatory procedures covering the full product lifecycle from pre-market through post-market Ability to create and deliver training materials for new or updated procedures Demonstrated ability to quickly learn and implement new quality management and regulatory standards A proactive self-starter with a positive, growth-oriented mindset Benefits Stock Options Medical, dental, vision insurance Life insurance Maternity and Paternity Leave Flexible time off 401K matching MacBook Pro Sponsorship for conferences, continuing education, etc. The annual US base salary range for this full-time position is $130,000 - $160,000 + equity + benefits. Pay scale is flexible depending on experience. Within the range, individual pay is determined by work location and additional factors, including job-related skills, competencies, experience, relevant education and training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

The Manager, Regulatory Affairs CMC is responsible for supporting and executing Regulatory CMC strategies in collaboration with cross-functional teams. This role manages CMC-related global regulatory submissions and Health Authority interactions to meet the project timelines for the assigned projects. This is a remote-based position located in the United States. Responsibilities: Support the development and implementation of Regulatory CMC strategies, including reviewing / authoring CTD CMC sections for assigned projects to ensure timely, high-quality global submissions for investigational, market, and post-approval applications Assist in preparing responses to Health Authority CMC questions, pre-meeting packages, and interactions for assigned projects Coordinate with the CMC team and other stakeholders to ensure timely submission of regulatory documents by tracking progress of document preparation Collaborate with cross-functional teams, especially CMC and Quality groups, to assess regulatory impact on CMC-related issues Contribute to regulatory risk assessment, identify key Regulatory CMC issues, and support mitigation activities throughout the product lifecycle Participate in developing internal Regulatory CMC guidance and working instructions Ensure proper Regulatory CMC assessment and actions are taken for recalls or product complaints during the product lifecycle Provide Regulatory CMC review for clinical protocols and investigator brochures for assigned projects Requirements Bachelor's degree in scientific disciplines required with expertise in at least one area in pharmaceutical development (chemical process, formulation, manufacturing, QC, QA, etc), MS/PhD is preferred Minimum of 5 years of related pharmaceutical or biopharmaceutical industry regulatory CMC experience Experience in leading the preparation of CMC modules to support CTA, NDA/MAA submissions, and subsequent responses to HA queries Expertise of ICH requirements and US/EU regulatory requirements Experience with regulatory CMC requirements for EU markets and GMP regulation Experience in authoring complex technical documents, CTD M2 and M3 sections, and life cycle management Experience with Veeva system preferred Excellent oral and written communications skills with attention to detail Strong project management skills, including coordinating teams and managing timelines for regulatory submissions Ability to demonstrate Elevar's core values by holding ourselves and each other accountable for the work we do, taking time to collaborate effectively while working remotely, making space or ingenuity in work and thought, and staying grounded in compassion The anticipated annual base salary range for this role is $125,000 to $160,000. Final compensation depends on multiple factors including but not limited to, relevant experience, skillset, depth and breadth of knowledge, internal equity, and external market factors. Elevar Therapeutics is a rapidly growing biotech company that offers competitive wages and benefits package including medical, dental, vision, time off, a retirement plan, and other voluntary benefits for employees. #LI-REMOTE

At Argenta, we're more than a company - we're a global team, dedicated to healthier animals. We believe that when their lives are made better, we're all the better for it. Founded in 2006, we support companies big and small to develop and manufacture health products for pets and livestock. Our trusted, innovative solutions and services cover every stage of the process, from molecule to market. We're in a unique position. We are the world's only combined contract research and contract development and manufacturing organisation (CRO/CDMO) dedicated to animal health. Our uniqueness means: We are ambitious, growing and building a ‘one team' culture, guided by our values. We are team players; We are doers; We are customer-centric; We are innovators . We value diversity, as a global company, we get the richness of working with different people in different places whether it be location, stages of their career, their development, their role. We believe that when everyone works together and puts their best “paw” forward we will make the lives of the animals we care for, better. With bases in New Zealand, the US, the UK and Europe, our 650+ colleagues are driven by our partnership approach and purpose: Healthy Animals. Let's Make It Happen, Together. TEAM PLAYERS who want to DO great work and find INNOVATIVE ways to make animals lives better through our CUSTOMER CENTRIC efforts should apply. Argenta is currently looking to fill the role of Senior Regulatory Affairs Manager within our CRO Americas division. About the role: Facilitates and supports the regulatory and drug development requirements of external clients and internal projects Effectively manage client and stakeholder expectations by providing timely, relevant, and accurate documents, assessments, reports and communications Demonstrates an awareness of current regulations, guidance's, regulatory processes, and the animal drug development process, while maintaining a flexible and creative mindset to work through regulatory challenges Creates regulatory solutions to complex issues Provides client accurate expert regulatory advice on animal health product development Represent Argenta in industry associations (e.g. GADA, AHI, SQA) Identify and pursue new regulatory consulting opportunities which may include meeting with new clients, traveling and speaking at professional meetings, networking in the industry and contributing to various publications Requirements: Bachelor's degree or equivalent experience in a scientific discipline, advanced degree (DVM, PhD, MS) is preferred 8+ years experience in veterinary regulatory and/or animal drug development Proven experience includes several of the following: CVM, E-Submitter, GLP, GCP, GMP, USDA, EPA, EMA Good written and oral communication skills, and ability to work collaboratively within and across teams Results and bottom line oriented Excellent analytical skills and attention to detail Proven influence, negotiation and persuasion skills Defines and plans priorities well. Comfortable balancing shifting priorities as required to meet business needs This position is subject to a DEA background check post offer and at regular intervals. This position is also required to complete a post offer drug test. Both the background and drug test must comply with company standards or offers of employment will be rescinded. You will also be someone who is aligned with our company values of "We are Doers, We are Team Players, We are Innovators, We are Customer-Centric". We pride ourselves on the uniqueness of our development and manufacturing abilities and the skills and qualities of our team. The position is a remote position working out of your home with domestic and occasionally international travel. Due to the nature of being a global organization, there may be times when this role works outside of normal business hours. Those times would be provided to the employee with plenty of notice. Want to know more about Argenta? Visit our website ********************* Equal Opportunity Employer

This position is responsible for acquiring and maintaining product registrations for domestic and international markets. Provide direction to the business as necessary regarding applicable U.S. and international regulations. Research and analyze applicable legislation and Federal, State and Local regulations to ensure the company's ongoing compliance. KEY RESPONSIBILITIES: Research and analyze applicable laws and regulations; develop and implement the necessary policies and procedures to ensure the Company's ongoing compliance with Federal, State and local requirements. Initiate and maintain medical device product registrations globally, focusing on international markets. Support the development of Regulatory strategies and processes. Works with subsidiary office personnel and distributors to provide direction and assistance in all matters of product legal/regulatory compliance, registrations and availability in domestic/international markets. Ensure only products legally registered are sold into international markets in accordance with U.S. export regulations. Assist in SOP development and review. Provide regulatory input to product lifecycle planning. Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions Determine and communicate submission and approval requirements Participate in risk benefit analysis for regulatory compliance Assess the acceptability of quality, preclinical and clinical documentation for submission filing Compile, prepare, review and submit regulatory submission to authorities Monitor impact of changing regulations on submission strategies Monitor applications under regulatory review Provide support during inspections and formulating the appropriate response and corrective actions Assist compliance with product post marketing approval requirements Review regulatory aspects of contracts Assist with label and Instructions for Use (IFU) development and review for compliance before release Ability to manage multiple establishment and product registration activities Submit and review change controls to determine the level of change and consequent submission requirements Provide regulatory input for product recalls and recall communications Other duties as assigned. SPECIFIC KNOWLEDGE & SKILLS: 2-4 years preferred experience in medical device (U.S. FDA regulated and registered) Manufacturer or Specification Developer in the U.S. and/or Foreign regulatory submissions. Experience with FDA pre-market submissions preferred. Experience with ISO 13485 and EU MDR preferred GENERAL SKILLS & COMPETENCIES: Good understanding of industry practices Proficient with tools, systems, and procedures Basic planning/organizational skills and techniques Good decision making, analysis and problem solving skills with ability to multi-task Good verbal and written communication skills Good presentation and public speaking skills Good interpersonal skills Basic conflict resolution skills Developing professional credibility MINIMUM WORK EXPERIENCE: Typically 2 to 4 or more years of increasing responsibility in terms of any applicable professional experience. PREFERRED EDUCATION: Typically a Bachelor's Degree or global equivalent in related discipline. TRAVEL / PHYSICAL DEMANDS: Travel typically less than 10%. Office environment. No special physical demands required. The posted range for this position is $61,812-$84,992, which is the expected starting base salary range for an employee who is new to the role to fully proficient in the role. Many factors go into determining employee pay within the posted range including prior experience, current skills, location/labor market, internal equity, etc. This position is eligible for a bonus not reflected in the posted range. Other benefits available include: Medical, Dental and Vision Coverage, 401K Plan with Company Match, PTO, Paid Parental Leave, Income Protection, Work Life Assistance Program, Flexible Spending Accounts, Educational Benefits, Worldwide Scholarship Program and Volunteer Opportunities. Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status. For more information about career opportunities at Henry Schein, please visit our website at: *************************** Fraud Alert Henry Schein has recently been made aware of multiple scams where unauthorized individuals are using Henry Schein's name and logo to solicit potential job seekers for employment. Please be advised that Henry Schein's official U.S. website is ******************* . Any other format is not genuine. Any jobs posted by Henry Schein or its recruiters on the internet may be accessed through Henry Schein's on-line "career opportunities" portal through this official website. Applicants who wish to seek employment with Henry Schein are advised to verify the job posting through this portal. No money transfers, payments of any kind, or credit card numbers, will EVER be requested from applicants by Henry Schein or any recruiters on its behalf, at any point in the recruitment process.

Business Unit: Global Regulatory Affairs Execution Team Employment Type: Contract Duration: 6+ months (with possible extensions) Rate: $46 - $50 /hr. W2. Posting Date: 6/27/2024. Notes: Only qualified candidates need apply. Fully remote. Approximately 30 hours per week. 3 Key Consulting is hiring! We are recruiting an Regulatory Writing Manager for a consulting engagement with our direct client, a leading global biotechnology company. Job Description: In this vital role you will prepare and coordinate the preparation of regulatory submission documents that comply with global regulatory standards. Day to day activities include: Write or lead all aspects of the writing of clinical study reports and Investigator Brochures for products in all phases of clinical development (phases 1-4) Write CTD sections including the Summary of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology, Summary of Biopharmaceutics, Clinical Overview, Table of All Studies, briefing documents, and safety narratives Write other regulatory submission documents (eg, RTQs, PIPs, white papers, breakthrough therapy applications, orphan drug applications) Lead study timelines for regulatory documents and regulatory submission strategy Act as a functional area representative and lead on product teams Assist with the following activities: hiring, resourcing therapeutic areas and project teams, and departmental governance Ensure quality of regulatory submission documents at all stages of development Provide expertise and mentorship on document design and principles of good medical writing to the department and product teams Participate in departmental meetings, as well as departmental and cross-departmental initiatives Top Must Have Skill Sets: Must have experience briefing documents with significant clinical content/Module 2 clinical summary documents. Looking for 3-5 years of experience with these document types. Masters or higher degree in biology, chemistry, or other scientific field 5+ years in writing clinical and regulatory documents Ability to optimally operate in an environment that involves negotiation, persuasion, collaboration, and analytical judgment Ability to analyze medical data and interpret its significance Sophisticated knowledge of scientific/technical writing and editing and of related regulatory guidance (eg, ICH) governing regulatory submission documents and industry compliance Basic Qualifications: Doctorate degree Or Master's degree and 3 years of Writing Regulatory or scientific submission/documents experience Or Bachelor's degree and 5 years of Writing Regulatory or scientific submission/documents experience Or Associate's degree and 10 years of Writing Regulatory or scientific submission/documents experience Or High school diploma / GED and 12 years of Writing Regulatory or scientific submission/documents experience Preferred Qualifications: Masters or higher degree in biology, chemistry, or other scientific field 5+ years in writing clinical and regulatory documents Ability to optimally operate in an environment that involves negotiation, persuasion, collaboration, and analytical judgment Ability to analyze medical data and interpret its significance Sophisticated knowledge of scientific/technical writing and editing and of related regulatory guidance (eg, ICH) governing regulatory submission documents and industry compliance Strong written/oral communication skills and attention to detail Understanding and application of principles, concepts, theories, and standards of scientific/technical field Strong time and project management skills, engaging approach, and perseverance with a drive for results Leadership skills and ability to guide and influence the work of others Strong leadership in a collaborative team environment Why is the Position Open? Supplement additional workload on team Interview Process: Phone screens and video conference We invite qualified candidates to send your resume to **************************. If you decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our website ******************************* You are also welcome to share this opportunity with anyone you think might be interested in applying for this role. Regards, 3KC Talent Acquisition Team

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.

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

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.

Our vision for the future is based on the idea that transforming financial lives starts by giving our people the freedom to transform their own. We have a flexible work environment, and fluid career paths. We not only encourage but celebrate internal mobility. We also recognize the importance of purpose, well-being, and work-life balance. Within Empower and our communities, we work hard to create a welcoming and inclusive environment, and our associates dedicate thousands of hours to volunteering for causes that matter most to them. Chart your own path and grow your career while helping more customers achieve financial freedom. Empower Yourself. As an Investment Advisory Compliance Program Office Manager, you will support compliance oversight for Empower Capital Management, Empower Advisory Group, and Empower Funds. You'll guide key elements of our compliance program, apply regulatory expertise, and help business partners operate with confidence. Your work strengthens our controls, supports regulatory readiness, and helps us deliver trustworthy advisory services. What you will do: Maintain and refresh compliance policies and procedures under the Advisers Act, Investment Company Act, and applicable FINRA/MSRB rules Review and test controls to assess effectiveness and partner with business teams to close gaps Prepare reports and filings for leaders, committees, and regulators Monitor regulatory changes and summarize impacts for advisory and fund businesses Coordinate exam and audit responses with senior compliance officers, including materials and follow-up Support compliance training by updating content, tracking completion, and answering questions Conduct due diligence on sub-advisers and third-party providers Work with Compliance Operations and technology partners to enhance reporting, testing, and automation Maintain documentation and records supporting regulatory obligations Represent Compliance on projects and working groups to embed requirements into new initiatives What you will bring: Bachelor's degree or equivalent experience 5+ years in investment advisory or asset management compliance Working knowledge of SEC, FINRA, and MSRB regulations Experience supporting compliance programs in a regulated financial institution Ability to interpret and apply complex regulations Strong analytical, organizational, and communication skills Comfort collaborating across teams and managing documentation Familiarity with compliance systems, reporting tools, or data management FINRA fingerprinting required What will set you apart: Advanced degree (J.D., MBA, or similar) FINRA Series 65 (or willingness to obtain within the required timeline) Experience with regulatory exams, audits, or control testing Background supporting advisory or fund compliance programs Strength in process improvement or automation tools Proven ability to explain regulatory expectations in clear, practical terms **Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time, including CPT/OPT.** What we offer you We offer an array of diverse and inclusive benefits regardless of where you are in your career. We believe that providing our employees with the means to lead healthy balanced lives results in the best possible work performance. Medical, dental, vision and life insurance Retirement savings - 401(k) plan with generous company matching contributions (up to 6%), financial advisory services, potential company discretionary contribution, and a broad investment lineup Tuition reimbursement up to $5,250/year Business-casual environment that includes the option to wear jeans Generous paid time off upon hire - including a paid time off program plus ten paid company holidays and three floating holidays each calendar year Paid volunteer time - 16 hours per calendar year Leave of absence programs - including paid parental leave, paid short- and long-term disability, and Family and Medical Leave (FMLA) Business Resource Groups (BRGs) - BRGs facilitate inclusion and collaboration across our business internally and throughout the communities where we live, work and play. BRGs are open to all. Base Salary Range $105,700.00 - $149,275.00 The salary range above shows the typical minimum to maximum base salary range for this position in the location listed. Non-sales positions have the opportunity to participate in a bonus program. Sales positions are eligible for sales incentives, and in some instances a bonus plan, whereby total compensation may far exceed base salary depending on individual performance. Actual compensation offered may vary from posted hiring range based upon geographic location, work experience, education, licensure requirements and/or skill level and will be finalized at the time of offer. Equal opportunity employer • Drug-free workplace We are an equal opportunity employer with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to age (40 and over), race, color, national origin, ancestry, sex, sexual orientation, gender, gender identity, gender expression, marital status, pregnancy, religion, physical or mental disability, military or veteran status, genetic information, or any other status protected by applicable state or local law. ***For remote and hybrid positions you will be required to provide reliable high-speed internet with a wired connection as well as a place in your home to work with limited disruption. You must have reliable connectivity from an internet service provider that is fiber, cable or DSL internet. Other necessary computer equipment, will be provided. You may be required to work in the office if you do not have an adequate home work environment and the required internet connection.*** Job Posting End Date at 12:01 am on: 01-17-2026 Want the latest money news and views shaping how we live, work and play? Sign up for Empower's free newsletter and check out The Currency.

Duties will include but not be limited to preparation and submittal of oil and gas regulatory applications and notices of work, including the ability to permit special projects with minimal direction/supervision; coordination with Division personnel to secure data required for regulatory filings required by OH Regulatory agencies. Prepare and file state and federal Class II/VI UIC applications where applicable. Work with local, State and Federal regulatory agencies to obtain appropriate approvals and provide necessary information to the same in order to comply with the regulatory requirements of the associated project. Maintain various spreadsheets and files to facilitate tracking the regulatory process for reporting to management.

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

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.

GCI's Regulatory Analyst II will create, implement, and ensure GCI's compliance with regulations. Prepare monthly carrier access billings and pool/settlement reporting; monitor and maintain access minute reporting functions; prepare, maintain, and interface with regulatory agencies filings for state and interstate tariffs, rate postings, Federal Universal Service Fund, and the Alaska Universal Service Fund; assist in preparation of cost studies and network use analyses; perform other regulatory/financial work. Keep appraising any regulation changes on both the state and federal side and offer interpretation. Prepare company tariffs and rate postings under both federal and state regulations. ESSENTIAL DUTIES AND RESPONSIBILITIES AT ALL LEVELS: Regulatory Filing Preparation and Analysis: Read and interpret FCC, RCA, and other regulatory entity rules, regulations, and procedures. Analyze and offer recommendations in response to any upcoming regulatory issues. Seek out, notify, and coordinate with other personnel within the organization to ensure process creation and ongoing compliance. Prepare reports and filings with regulatory bodies to ensure accurate receipt of Universal Service fund support and pooled earnings. Create processes, interpret changes, and maintain accurate documentation regarding each filing and the regulation or rule driving it. Tariff/Posting Preparation: Audit, preparation and filing of access tariffs as well as tariff interpretations and quotes; maintenance of local and long-distance rate postings, terms, and conditions. Coordination with other departments to maintain compliance. Streamline and automated processes where necessary. Access Minute Management: Act as first point of contact for Local Exchange Carrier (LEC) CABs preparers. Manage trunk tables to ensure accurate access minutes are being captured and review monthly files sent to LECs. Work closely with IT Analysis to ensure data integrity. Calculate quarterly billing factors and maintain records sufficient for audit. Carrier Access Billing (CABs): Prepare monthly CABS billing and related analysis. Use reports from the CABs system as needed to analyze trends and monitor the integrity of the CABs bill. Follow-up and resolve any trend analysis anomalies. Reconcile and balance billing reports used for Connect America Fund (CAF) filings. File Network Access Fee (NAF) revenues, Intrastate minutes of use, and switched circuits in the Alaska Exchange Carriers Association (AECA) portal. COMPETENCIES: + ACCOUNTABILITY- Takes ownership for actions, decisions, and results; openly accepts feedback and demonstrates a willingness to improve. + BASIC PRINCIPLES - Interacts with people in a way that builds mutual trust, confidence, and respect; adheres to GCI's Code of Conduct for Employees - the Basic Principles. + COLLABORATION - Works effectively with others to accomplish common goals and objectives; maintains positive relationships even under difficult circumstances. + COMMUNICATION- Conveys thoughts and expresses ideas appropriately and professionally. + Ability to accurately communicate information virtually (i.e., Teams), over the phone, and in-person in a clear and concise manner to a range of audiences. + Ability to accurately read, write, and respond to business correspondence such as emails, chat messages, policies, procedures, reports. + Ability to multitask in a faced paced environment with successful results. + COMPLIANCE - Follows internal controls; protects confidential information; abides by GCI's Code of Business Conduct & Ethics. + CUSTOMER FOCUS - Demonstrates commitment to service excellence; gives high priority to customer satisfaction. + RELIABILITY - Consistently follows through on assigned tasks as expected; demonstrates timely attendance at meetings, training, and other work obligations. + RESULTS - Uses a combination of job knowledge, initiative, sound decision making, innovation, adaptability, and problem solving. + SAFETY & SECURITY - Supports a safe work environment by following all workplace safety rules and guidelines; complies with applicable Security policies and procedures. + TECHNICAL PROFICIENCY - Proficient computer skills and MS Office knowledge (e.g., Outlook, Teams, Word, Excel) to complete job duties effectively, such as using the company intranet and to accurately retrieve and input information into database or equivalents. Additional Job Requirements: Intermediate level analyst position. Must have a comprehensive understanding of telecommunications, and ability to follow documented procedures with no supervision. Works under moderate supervision and supports team. Requires ability to execute complex procedures. High degree of self-initiative and be able to prioritize and handle multiple tasks with independent decision-making. Individual must lead team members and effectively communicate directions. Minimum Qualifications: Required: *A combination of relevant work experience and/or education sufficient to perform the duties of the job may substitute to meet the total years required on a year-for-year basis + High School diploma or equivalent. + Bachelor's Degree in business administration, Finance, Economics, or related field.* + Minimum six (6) years of increasing responsibility in regulatory, compliance or related regulated industry experience. * Preferred: + Four (4) years of experience working in the telecommunications industry for mid- to large-size private business. + Other relevant telecom industry or job specific certifications. DRIVING REQUIREMENTS: + This position may require access to reliable transportation for occasional travel between retail store locations, offices, worksites, or other locations as needed. PHYSICAL REQUIREMENTS and WORKING CONDITIONS: + Work is primarily sedentary, requiring daily routine computer usage. + Ability to work shifts as assigned, work in standard office/home office setting, and operate standard office equipment. + Ability to accurately communicate information and ideas to others effectively. + Physical agility and effort sufficiently to perform job duties safely and effectively. + Ability to make valid judgments and decisions. + Available to work additional time on weekends, holidays, before or after normal work hours when necessary. + Must work well in a team environment and be able to work with a diverse group of people and customers. + Virtual workers must comply with remote work policies and agreements. The company and its subsidiaries operate in a 24/7 environment providing critical services to Alaskans and may need to respond to public health and safety matters or other business emergencies. Due to business needs employees may be contacted outside of the core business hours to respond to the immediate emergency. As such, you will be requested to provide emergency after-hour contact numbers, to include your home and cell phone numbers if you have those services. Culture, Engagement, and Connection: At GCI, we foster an environment where the unique perspectives of our employees, customers, and fellow Alaskans are celebrated. We add value to our community by nurturing and empowering each member of our workforce, ensuring equal opportunities for every Trailblazer. EEO: GCI is an equal opportunity employer. Qualified applicants are considered for employment without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, marital status, mental or physical disability, veteran status, or any other status or classification protected under applicable state or federal law. DISCLAIMER: The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. All employees of GCI work in support of the GCI Mission Statement and Declaration of Principles which are located on the GCI Career page and Employee portal.