Senior Director, Regulatory Affairs Job at Beam Therapeutics (Cambridge)

Associate Director Regulatory Affairs

The Associate Director is a senior people leader responsible for the operational...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree, 12 years of experience in CMC and/or Device regulatory, and 5 years of leadership experience
Master’s degree and 14 years of experience in CMC and/or Device regulatory, and 6 years of leadership experience
Bachelor’s degree, 15 years of experience in CMC and/or Device regulatory, and 7 years of leadership experience

Job Responsibility

Provide inclusive, inspiring leadership for staff within the CMC & Device Regulatory team in AIN
Attract, hire, develop, and retain top regulatory talent
foster a culture of learning, engagement, inclusion, and high performance
Ensure staff receive appropriate onboarding, development, and ongoing support
Promote behaviors and ways of working consistent with Amgen’s values and leadership attributes
Oversee and be accountable for regulatory work performed by AIN staff, including global change assessments, state and federal licensure, submission execution, periodic reporting and process enhancements
Partner closely with functional and regulatory leadership to drive strategic alignment across Amgen’s products
Ensure high-quality, timely, and compliant regulatory deliverables
Build and maintain strong partnerships with global functional leaders and internal stakeholders
Serve as a trusted and proactive cross-functional partner

What we offer

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

Regulatory Affairs Senior Director - Global Regulatory Leader - Obesity

In this vital role you will support products in the Obesity Therapeutic Area. Gl...

Location

United States

Salary:

220356.00 - 269853.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 5 years of regulatory experience in biotech or science
Master’s degree and 8 years of regulatory experience in biotech or science
Bachelor’s degree and 10 years of regulatory experience in biotech or science

Job Responsibility

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

What we offer

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

Fulltime

Senior Director, Clinical and Regulatory Writing

The Senior Director, Clinical and Regulatory Writing will serve as a strategic l...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Advanced degree in life sciences (M.D., or PharmD preferred)
MS, PhD with significant clinical pharmacology writing experience will be considered
12+ years of progressive experience in regulatory or scientific/medical writing in the biopharmaceutical industry, including 5+ years in a leadership role
Demonstrated experience developing content for major global regulatory submissions (e.g., IND, BLA, MAA), preferably in cell or gene therapy
Strong understanding of drug development processes, regulatory frameworks (FDA, EMA, ICH), and clinical trial documentation requirements
Exceptional writing, editing, and analytical skills with the ability to convey complex scientific data clearly and persuasively
Proven leadership capabilities, including team development, cross-functional collaboration, and vendor management
Proficiency in Microsoft Office Suite, document management systems (e.g., Veeva Vault), and electronic publishing tools
Strong project management skills with the ability to prioritize competing demands in a fast-paced, deadline-driven environment
Collaborative mindset with the ability to influence and guide stakeholders across disciplines and levels of seniority

Job Responsibility

Lead the clinical writing function in the development, review, and approval of regulatory documents to support global submissions (e.g., INDs, IMPDs, BLAs, MAAs, Orphan Drug Applications, Investigator Brochures, protocols, clinical study documents, PSPS/POIPs, Prime, RMAT)
Lead cross-functional content planning of regulatory submission modules, including data integration and interpretation, and ensuring consistency in strategic messaging for dossiers, meeting packages and responses to health authorities
Translate complex technical data from clinical and biostatistics teams into scientifically accurate, submission-ready documentation
Manage external consultants and contractors as needed to support Cabaletta submissions reviews, authoring, if needed, and gap analyses
Mentor, train, and manage a team of medical/regulatory/technical writers or cross-functional contributors in document development
Develop and implement strategic plans for medical writing activities, aligning them with clinical development, regulatory affairs, and overall business goals
Drive process improvements and develop standard practices for efficient, compliant and high-quality document delivery
Collaborate with Clinical Operations and external CROs to ensure inspection readiness of clinical trial documentation, including informed consents, study manuals, and IRB/IBC responses

What we offer

health and retirement, PTO, and stock option plans

Senior Director of Renewables, Campaigns

The Senior Director of Renewables, Campaigns will focus on advancing renewable e...

Location

United States

Salary:

140000.00 - 155000.00 USD / Year

Action for the Climate Emergency

Expiration Date

Until further notice

Requirements

10+ years of experience in the US power sector with expertise in renewable energy development, regulatory permitting, stakeholder engagement, policy advocacy, or public affairs within the energy industry
Bachelor's degree in a relevant field or equivalent experience
Demonstrated ability to design and execute campaigns, particularly at the state and local levels
Exceptional communication and writing skills
Proven experience building coalitions and engaging stakeholders across sectors
Demonstrated expertise in researching and analyzing policy and regulatory landscapes
Experience using renewable energy databases like Enverus, Curate, Landgate and AI tools
Strategic thinking capabilities with deep understanding of data use and ability to inspire and lead diverse teams
Strong project management skills
Self-starter who is proactive, flexible, and solutions-oriented

Job Responsibility

Support strategy development including drafting internal and external plans, memos and playbooks for accelerating deployment
Share and leverage subject matter expertise in community engagement, stakeholder relations, and project deployment across a variety of renewable energy technologies
Develop guides and collateral for engaging with local officials, stakeholders, and communities to promote renewable energy projects
Build and maintain relationships with renewable energy developers, policymakers, community leaders, funders, partners and other key stakeholders
Draft reports, memos, letters and other communications funders, developer clients, and other critical stakeholders as needed
Support advocacy efforts for policy and regulatory changes that streamline renewable energy deployment locally, at the state-level and nationally where applicable
Represent the organization at industry events, public hearings, and community forums to promote renewable energy initiatives
Support community engagement efforts with partners and other stakeholders, including town halls, community events, or other opportunities
Identify and analyze regulatory and policy opportunities to support renewable energy permitting and development-friendly ordinances
Conduct research on advocacy strategies, regulatory barriers, and best practices to inform campaign and outreach efforts

What we offer

Medical
Dental
Vision
403b retirement savings plan
Vacation
Sabbatical
Paid Parental Leave
2 Floating Holidays
2 Community Service Floating Holidays
Sick time

Fulltime

Director Legal Affairs

We are a fast-paced, growth-driven company seeking an experienced and business-m...

Location

United States of America , San Antonio

Salary:

Not provided

Circle K

Expiration Date

Until further notice

Requirements

Licensed Attorney: Active license to practice law in good standing in at least one U.S. jurisdiction
Experience: Minimum of 10 years of legal practice, ideally a combination of top-tier law firm and in-house corporate legal department experience
Industry Expertise: Strong experience advising clients in the retail, convenience store, or petroleum industries highly preferred
Legal Skillset: Mastery in contract drafting, negotiation, regulatory compliance, privacy, and business counseling
Exceptional Communicator: Outstanding writing, verbal communication, and interpersonal skills, with the ability to influence and advise senior leadership
Self-Starter with Collaborative Spirit: Ability to work independently while thriving in a cross-functional, global environment
Relationship-Builder: Proven track record of developing strong internal and external professional relationships
Organized and Detail-Oriented: Excellent organizational skills with the ability to manage multiple complex projects simultaneously under tight deadlines
Positive and Strategic Mindset: A proactive, solutions-oriented approach with a positive attitude and a strong commitment to excellence

Job Responsibility

Serve as a trusted advisor to senior management, offering strategic guidance that balances legal risk with business objectives
Draft, negotiate, and review contracts at global, national, regional, and local levels across procurement, fuel operations, IT, marketing, and general business operations
Provide strategic counsel to global fuel teams on supply, distribution, regulatory, and transactional matters
Navigate a broad regulatory landscape, ensuring compliance with FTC competition laws, liquor licensing, environmental regulations, lottery rules, and local/state legal requirements
Oversee privacy compliance initiatives to ensure alignment with evolving U.S. privacy laws and regulations
review and negotiate privacy-related contracts
Review, draft, and negotiate IT contracts and technology agreements
Support marketing initiatives by drafting disclaimers, contest rules, terms and conditions, and providing risk mitigation advice on promotions and campaigns
Identify, recommend, and implement improvements that streamline legal department operations and enhance overall business efficiency
Provide education, training, and mentoring to internal legal team members and business units

What we offer

Work closely with executive leadership on critical business initiatives
Support a growing, global company with diverse legal challenges
Opportunities for leadership and career advancement

Fulltime

Director, European Regulatory and R&D Policy

In this vital role you will be responsible for creating an optimal regulatory en...

Location

United Kingdom , Uxbridge; Cambridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree in public health, life sciences, public policy, business administration and/or law degree
Demonstrable experience in policy development, analysis and influencing
Demonstrable experience in successfully executing global regulatory policy strategies
Experienced solutions-orientated self-starter

Job Responsibility

Leading the development and execution of strategic plans for each assigned policy area
Ensure that Amgen’s regulatory, safety and R&D policy positions are successfully represented to inform policy development and implementation
Provide internal stakeholders with strategic regulatory policy perspectives
Guide and advise senior leadership in selecting issues, establishing priorities and developing and implementing regulatory policy advocacy plans
Support the creating of necessary infrastructure/processes for developing the regulatory policy function
Influence the development and articulation of Amgen’s position on regulatory policies that impact Amgen’s business
Represent Amgen in interactions with external regulatory, political, policy and professional organisations in a manner that aligns with the “one Amgen’ approach”

What we offer

Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

Director, Regulatory Affairs – Americas & ANZ

As Director Regulatory Affairs (Americas & ANZ), you set and lead the regulatory...

Location

United States

Salary:

154000.00 - 230000.00 USD / Year

ResMed

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs or equivalent
advanced/regulatory certification (e.g., RAC) highly desirable
Minimum 10 years of regulatory affairs experience in medical devices (Class II/III, SaMD, combination products), with significant experience in Americas markets (US, Canada, LATAM)
At least 3–5 years in a leadership role managing regulatory teams and interfacing with cross-functional business stakeholders
Deep knowledge of MD regulatory frameworks: FDA (21 CFR, QSR), Health Canada, ISO 13485/MDSAP, LATAM device regulations — demonstrated ability to navigate complex, multi‑jurisdictional regulatory environments
Strategic mindset and business acumen: ability to translate business goals into regulatory strategy, balance compliance and commercial objectives, drive enterprise‑level initiatives
Excellent stakeholder management, communication, influencing, and negotiation skills (internal leadership, external authorities, business partners)
Fluent in English, with Spanish and/or Portuguese strongly preferred for LATAM coverage
Willingness to travel across Americas region
flexible to address regulatory or business needs globally as required

Job Responsibility

Define and lead the Regulatory Affairs roadmap for Americas in alignment with global corporate strategy and regional Revenue ambitions
Represent Regulatory Affairs in regional leadership, commercial planning and strategic cross-functional meetings including but not limited to Revenue, Marketing, Supply Chain, Operations, Quality, Legal
Lead strategic high-complexity/ high-risk regulatory projects
Active member of the RA Leadership Team fostering collaboration and contributing to build the future of the Regulatory Affairs function
Oversee the preparation & submission of regulatory filings (including both product & facility licensing/registration) within Americas for all class and type of Products
Anticipate regulatory trends and shifts (US, Canada, LATAM, ANZ), shape proactive strategies (policy monitoring, engagement with regulators, participation in industry associations), influence external regulatory landscape as appropriate
Drive global-to-regional alignment: ensure Americas regulatory approach aligns with global RA standards while adapting to local market needs
propose harmonization initiatives for labeling, documentation, submission processes across region
Ensure robust compliance framework for Americas: audit readiness (MDSAP, ISO 13485, FDA QMS compliance), risk management, regulatory intelligence dissemination, crisis readiness (e.g., regulatory actions, recalls)
Build, mentor and develop the Americas + ANZ RA organization: talent development, performance management, succession planning, ensure adequate skills and capacity to meet strategic demands

What we offer

comprehensive medical, vision, dental, and life, AD&D, short-term and long-term disability insurance, sleep care management, Health Savings Account (HSA), Flexible Spending Account (FSA), commuter benefits, 401(k), Employee Stock Purchase Plan (ESPP), Employee Assistance Program (EAP), and tuition assistance
Flexible Time Off (FTO), receive 11 paid holidays plus 3 floating days and are eligible for 14 weeks of primary caregiver or two weeks of secondary caregiver leave when welcoming new family members

Fulltime

Senior Manager, Government & Regulatory Affairs

GEICO is seeking an accomplished government relations professional to join our t...

Location

United States , Sacramento

Salary:

158875.00 - 248050.00 USD / Year

Geico

Expiration Date

Until further notice

Requirements

Juris Doctor (JD) degree from an accredited law school and admission to practice law in at least one U.S. jurisdiction highly preferred
Minimum 10 years’ relevant government affairs experience with knowledge of insurance regulation, regulatory law, or related public policy fields, preferably within property and casualty insurance
knowledge of auto insurance a plus
Proven experience, with a track record of successfully developing and implementing regulatory and legislative strategies
Deep knowledge of U.S. insurance regulatory systems, including state insurance departments and the National Association of Insurance Commissioners
Strong analytical skills, with the ability to translate complex regulatory developments into actionable business strategies
Strong verbal and written communication and presentation skills tailored to different audiences
Exceptional communication, negotiation, and interpersonal skills, with a collaborative approach to working within cross-functional teams
Ability to balance independent legal judgment with teamwork and enterprise-wide policy development processes
Ability to articulate GEICO’s positions in an impactful and persuasive manner to decision makers and industry leaders and to offer strategic advice on complex legislative and regulatory issues to business professionals

Job Responsibility

Policymaker Engagement: Build and maintain a strong network of key policymakers, including state legislators, heads of relevant executive agencies and their staff, industry members, policymakers (NAIC and NCOIL), and trade associations to efficiently and effectively advocate GEICO’s positions in assigned states. Develop comprehensive strategic plans to facilitate effective engagement with legislative and regulatory stakeholders to achieve GEICO’s business objectives
Regulatory & Legislative Analysis: Review and evaluate impactful insurance regulatory/ legislative proposals, working in close collaboration with relevant Government & Regulatory Affairs colleagues and other internal stakeholders. Ensure that GEICO's business units and corporate functions remain informed about critical and emerging issues
Strategic Monitoring & Reporting: Proactively identify evolving regulatory and legislative trends and effectively communicate relevant insights and potential risks to the Government & Regulatory Affairs team, business units, and senior management to support informed, enterprise-wide strategic decision-making
Strategic Support: Work with the Director of Public Policy and business stakeholders to develop policy positions, strategy, responses/draft language
prepare for legislative and regulatory interactions
and support company’s strategic initiatives
Coalition Building: Support the strategic implementation of GEICO’s key public priorities through coalition building and coordination of external resources. Maximize outside firms and association memberships to successfully advocate GEICO’s priorities. Develop and execute effective and efficient political contributions strategies in assigned states, in consultation with business, to enhance GEICO’s policy agenda
Additional Duties: Assume other regulatory or legislative responsibilities as priorities evolve

What we offer

Comprehensive Total Rewards program that offers personalized coverage tailor-made for you and your family’s overall well-being
Financial benefits including market-competitive compensation
a 401K savings plan vested from day one that offers a 6% match
performance and recognition-based incentives
and tuition assistance
Access to additional benefits like mental healthcare as well as fertility and adoption assistance
Supports flexibility- We provide workplace flexibility as well as our GEICO Flex program, which offers the ability to work from anywhere in the US for up to four weeks per year

Fulltime

Senior Director, Regulatory Affairs

Beam Therapeutics

Location:
United States , Cambridge

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
March 04, 2026

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