Director of Regulatory Affairs Job at Life Science Talent (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

Director, Regulatory Labeling

Beam is seeking a Director of Regulatory Affairs – Advertising, Labeling, and Pr...

Location

United States , Cambridge

Salary:

210000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

BS required
an advanced degree (i.e. MS, PharmD, PhD, MD) is a plus
A minimum of 6 years of experience working in Regulatory Affairs Advertising, Labeling, and Promotion
ideally 15 plus years in the biotech industry with at least 8 years in regulatory affairs
Record of success with interactions with Regulatory Agencies and Health Authorities as part of label negotiations and label updates
Comprehensive knowledge of US and global regulatory procedures and practices
Extensive experience with regulatory documents and filings (IND, CTA/IMPD, BLA, MAA, PIP)
Strong strategic thinking and problem-solving skills
Experience in representing programs to internal and external stakeholders
Ability to develop collaborative working relationships internally as well as externally with physicians, expert consultants, and contracted vendors

Job Responsibility

Lead the creation, review, and approval of critical regulatory labeling documents including Core Data Sheet and Regional Labels for Beam hematology programs in alignment with Target Product Profiles
Lead labeling negotiations between Beam and health authorities as part of marketing authorization applications
Create regulatory labeling processes and associated SOPs, Work Instructions, and any other required documentation
Represent Regulatory Affairs as part of the Promotional Review Process
Incorporate the evolving global regulatory requirements and guidance's with respect to gene editing and gene therapy, rare disease, and prescription drug labeling
Provide innovative regulatory approaches, solutions and guidance to cross-functional teams while mitigating regulatory risks
Guide and assist on the planning, preparation, writing and submission of regulatory documentation
Manage project plans and timelines to ensure all projects are prioritized appropriately and milestones and goals are met on time
Provide regulatory due diligence as required
Supervise and mentor direct reports

Fulltime

Associate Director, Regulatory

This role will serve as the Regulatory Lead for our pivotal program leading to B...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor's degree in life sciences or related field required (advanced degree preferred)
Minimum of 5 years of experience in regulatory affairs for biopharmaceuticals or cell therapy (preferred)
Strong understanding of the drug development process from pre-clinical to commercialization, (prior BLA experience required)
Experience in reviewing and writing regulatory submission documents for global regulatory filings such as IND, CTAs, and BLAs/MAAs and related health authority interactions
Knowledge of GXPs and key requirements for clinical, nonclinical and CMC documentation for regulatory submissions in ICH regions
Excellent communication, negotiation, and leadership skills
Strong team orientation and passion for continuous self-development

Job Responsibility

Regulatory Strategy Development: Manage all regulatory aspects of Cabaletta’s lead program through pivotal clinical studies and BLA/MAA approval, including the preparation of clinical trial applications, amendments, correspondence, applications for expedited programs, health authority meetings, marketing applications, and labeling and promotional reviews for regulatory agencies, including FDA, Health Canada, EMA, MHRA and other countries, as applicable
Collaborate with cross-functional teams including clinical and nonclinical development, manufacturing, quality assurance, and medical affairs to develop and implement competitive regulatory strategies that expedite development and maximize the probability of success for cell therapy product development
Stay informed about evolving regulations and guidelines related to cell therapy and adapt strategies accordingly
Assess and communicate potential regulatory risks and propose mitigation plans
Regulatory Submissions and Compliance: Prepare and oversee the submission of regulatory documents, including INDs, CTAs, BLAs/MAAs, and other relevant submissions to regulatory agencies (e.g., FDA, EMA)
Ensure the quality and accuracy of regulatory submissions, adhering to timelines and requirements
Ensure compliance of programs and submission documentation with current regulations and guidelines governing cell therapy products
Regulatory Interactions: Represent the company during interactions with regulatory agencies, including meetings, teleconferences, and written communication
Prepare meeting requests, briefing documents, and coordinate and prepare teams for meetings with health authorities
Coordinate and prepare responses to requests for information from regulatory agencies

What we offer

health and retirement, PTO, and stock option plans

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

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, Regulatory Affairs

Senior Director role in Regulatory Affairs at Beam Therapeutics, a biotechnology...

Location

United States , Cambridge

Salary:

260000.00 - 320000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s Degree or foreign equivalent, in regulatory affairs
or a closely related field
Five (5) years of progressive, post-baccalaureate experience including: Working in regulatory affairs
Developing regulatory documents and submissions
and Presenting corporate development programs to regulatory agencies
The required five years must also include at least one year of experience (which may have been gained concurrently) involving: Regulatory affairs work within biotechnology specifically, including application of U.S. and global regulatory procedures and practices
Developing regulatory documents and submissions such as IND, CTA/IMPD, BLA, MAA and PIP
and Managing projects in biotechnology regulatory affairs

Job Responsibility

Supporting development and implementation of global regulatory strategy for innovative genetic medicine programs within a fast-paced biotechnology environment
Ensuring integration of regulatory tactics with broader corporate strategy across non-clinical, clinical and commercial development stages
Incorporating evolving United States and global regulatory requirements related to gene editing, gene therapy, rare disease, orphan indications, breakthrough therapies and expedited regulatory pathways
Representing the Regulatory Affairs function on cross-functional and project teams to provide regulatory input throughout development
Developing innovative regulatory approaches, solutions and guidance while mitigating regulatory risks
Collaborating with external stakeholders, including experts, consultants and contracted vendors
Guiding planning, preparation, construction and submission of regulatory documentation
Managing project plans, timelines and prioritization to ensure milestones and goals are achieved
Providing regulatory due diligence support

Fulltime

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Director of Regulatory Affairs

Job Description

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