Director, Regulatory Labeling Job at Beam Therapeutics (Cambridge)

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

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

Manager/Senior Manager Regulatory Affairs – Advertising, Labeling, and Promotion

The Manager/Senior Manager, Regulatory — Advertising, Labeling, and Promotion (A...

Location

United States , Cambridge

Salary:

130000.00 - 190000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a scientific discipline required
advanced degree preferred
8+ years (Manager) 10+ years (Senior Manager) experience in Regulatory Advertising & Promotion
Strong understanding of FDA promotional regulations (FD&C Act, 21 CFR 202.1, OPDP/OC, CBER/CDER)
Hands-on PRC/MLR experience and 2253 submission experience required
Excellent communication, cross-functional collaboration, and regulatory judgment

Job Responsibility

Serve as Regulatory lead for PRC/MLR review of promotional, disease awareness, scientific exchange, HCP, and patient-directed materials for certain products, under the supervision of the Director of Regulatory Labelling
Manage the lifecycle of core and regional labeling documents including updates, reviews, approvals, and submissions
Ensure claims are truthful, non-misleading, balanced, and aligned with approved labeling and scientific evidence
Prepare and submit FDA Form 2253 filings
maintain records and track OPDP correspondence in conjunction with regulatory operations
Ensure alignment with promotional materials with CCDS, USPI/PI, IFU, and patient labeling
Monitor FDA OPDP/CBER guidance's, enforcement trends, and evolving U.S. regulations
educate internal teams
Support development of SOPs, governance documents, training programs, and inspection readiness activities
Advise cross-functional partners on scientific substantiation, evidence gaps, and claims strategy

Fulltime

Senior Product Developer

The Senior Product Developer (NPD & Commercialization) is a senior technical and...

Location

Canada , Mississauga

Salary:

80000.00 - 90000.00 CAD / Year

Randstad

Expiration Date

April 20, 2026

Requirements

Bachelor’s degree in Food Science, Food Engineering, or a related scientific discipline, or equivalent combination of education and relevant experience
Minimum 8 years of experience in food product development, preferably within baked goods or commercial food manufacturing
Proven experience leading product commercialization and scale-up in a manufacturing environment
Demonstrated experience integrating packaging design into product development and launch execution
Strong understanding of ingredient functionality, formulation development, nutrition, regulatory compliance, and clean label considerations
Solid knowledge of food manufacturing processes, equipment, and production constraints
Demonstrated leadership capability, including experience coaching, mentoring, or guiding others in a technical environment
Highly organized, structured, and disciplined in project execution and documentation
Strong analytical, problem-solving, and communication skills
Proficiency in MS Office, ERP systems, and formulation/nutrition software (e.g., Genesis or similar)

Job Responsibility

Own the execution of product development and commercialization projects, ensuring clear scope, timelines, responsibilities, and deliverables from concept through launch
Lead products through all development stages, including bench-top development, feasibility trials, plant trials, and first production
Ensure products are technically and operationally ready for launch, with validated formulations, processes, packaging, specifications, and documentation
Review and validate formulations, ingredients, and nutritional information to ensure compliance with regulatory requirements, clean label standards, and customer and market expectations
Partner with QA, Regulatory, and Supply Chain to ensure ingredient selections meet functional, nutritional, labeling, and cost targets throughout development and commercialization
Proactively identify technical, operational, packaging, supply, and compliance risks and drive mitigation plans early in the development cycle
Lead and enforce stage-gate discipline, ensuring projects meet defined readiness criteria before progressing
Partner with Operations to ensure products are designed for manufacturability on existing and new production lines
Plan, coordinate, and lead production trials, and support first productions, ensuring structured execution, clear ownership, and documented outcomes
Ensure learnings from trials are captured, documented, and incorporated into final product designs, formulations, and specifications

What we offer

Competitive salary and company benefits
Opportunities for professional learning, development, and growth
Working with a fun, exciting, and supportive team

Fulltime

Senior Director – Global Regulatory Strategy Biologics

I am actively seeking a Senior Director, Global Regulatory Strategy for a rapidl...

Location

Switzerland , Geneva

Salary:

Not provided

NonStop Consulting

Expiration Date

Until further notice

Requirements

A life sciences degree (or equivalent scientific background)
15+ years of experience in international regulatory affairs
Proven leadership experience managing senior regulatory professionals
Hands-on experience with global submissions (e.g. BLA, MAA)
Deep understanding of regulatory strategy across development and lifecycle stages
Strong experience leading interactions with global health authorities
The confidence to challenge convention and shape regulatory approaches in a rapidly evolving environment
Excellent communication, stakeholder management, and decision-making skills
Fluency in English
additional languages are a plus

Job Responsibility

Owning and leading global regulatory strategies for biosimilar development and lifecycle management
Acting as the primary regulatory interface with health authorities (e.g. EMA, FDA), including leading scientific advice, briefing meetings, and submissions
Developing clear, persuasive regulatory narratives and submission strategies aligned with business and development goals
Guiding global and regional teams on regulatory positioning, launch readiness, labelling, and post-approval activities
Supporting market prioritisation and launch sequencing through regulatory insight
Driving consistency, quality, and innovation across regulatory processes and systems
Building, mentoring, and leading a high-performing global regulatory team
Representing the organisation externally within regulatory forums, industry groups, and key partnerships