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

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

Medical Director, Pharmacovigilance

Reporting to the Senior Medical Director, Global Patient Safety and Pharmacovigi...

Location

United States , Waltham

Salary:

205000.00 - 250000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

8+ years of experience in global pharmacovigilance
2+ years of experience in clinical practice or academic medicine
Proven experience in safety data analysis, signal management, and benefit-risk evaluation
Working knowledge of safety databases (Argus, ArisG/LifeSphere Safety, or similar)
Demonstrated ability to develop and implement drug safety strategies, risk management plans, and safety governance models
Proven experience with authoring or contributing to clinical study and regulatory submission documents
Thorough knowledge of relevant FDA and International Conference on Harmonization (ICH) guidelines, including Good Clinical Practices (GCP) guidelines
Strong knowledge of global safety and pharmacovigilance regulations, guidelines, and industry standards (FDA, EMA, ICH, GVP)
Experience in creating or managing working documents such as SOPs or Work Instructions
Strong ability to proactively identify risks and initiate/manage risk minimization activities

Job Responsibility

Provide expert medical interpretation of safety data from all sources and perform medical review of Individual Case Safety Reports (ICSR) within the ARGUS database
Oversee and execute safety signal detection and evaluation activities
Incorporate insights from real-world data into surveillance and benefit-risk assessments
Lead the development and oversight of global benefit-risk assessments and safety surveillance
Drive the lifecycle management of Risk Management Plans (RMPs) and other risk minimization strategies
Lead the authoring and medical review of safety sections for regulatory documents and safety modules for marketing applications
Support labeling decisions and contribute medical expertise to safety communications
Collaborate with cross-functional stakeholders to integrate safety considerations
Lead and inspire a team of PSPV MDs, scientists, and operational colleagues
Partner with senior leadership on departmental goals, organizational design, budgeting, and long-term pharmacovigilance planning

What we offer

Comprehensive health coverage
Flexible time off
Paid holidays
Year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Tuition reimbursement
Commuter benefits
Disability and life insurance
Annual bonus opportunities

Fulltime

Senior Director, Global Medical Lead – Lysosomal Storage Disorders

The Global Medical Lead, Sr. Director level, is a critical leadership role in Gl...

Location

Switzerland

Salary:

Not provided

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

MD, PhD, PharmD or other advanced life sciences degree required
Extensive industry experience, especially in Medical Affairs (≥ 7 years) and Clinical Development, ideally in global roles
Experience in LSDs/inherited metabolic conditions is desirable, either in pharmaceutical/clinical research or a clinical environment
Experience in Genetic Medicine is a plus
Ability to work, influence, and gain consensus across regions and cross-functional teams
Demonstrate solid understanding of cross-functional inter-dependencies across the drug development lifecycle
Excellent communication skills and a strong enterprise mindset required for problem solving and high-level presentations for senior executive staff review
US and international experience working in orphan or specialty markets
Have ability to design studies, develop protocols and monitor studies in a wide range of study types and phases including pre and post marketing
Knowledgeable and current in GCP guidelines and compliance rules globally

Job Responsibility

Leads development, execution, and communication of the Global Medical Plan in collaboration with other internal stakeholders across BioMarin
Provides subject matter expertise as well as leadership in key internal medical and clinical teams, called SMART teams, where s/he leads development of the medical plan and ensures that all critical components of medical plans are executed and monitored for the intended impact
Act as product and disease area expert and primary contact point for all global compound or disease area related issues both internally and for the external community
Develop Medical Affairs launch strategy and roadmap and lead all Medical Affairs launch activities in collaboration with Commercial and other key stakeholders
Represent Medical Affairs in development of regulatory documents and submissions (e.g. briefing books, protocols, label discussions etc.)
Represent Medical Affairs at FDA/EMA meetings
Leads the Integrated Evidence Team for development of the integrated evidence package for the therapeutic area. Ensures timely execution of the plan to ensure data gaps are filled optimizing patient access
Responsible for providing medical input into development, execution and interpretation of Clinical Development Plans, clinical protocols, including review of draft external research protocols, reports and manuscripts
Oversight of clinical registries and other post-marketing commitments
Evaluation of safety issues associated with product in collaboration with other departments

Quality Assurance Manager

The Quality Assurance (QA) Manager provides site-specific quality oversight and ...

Location

United States , Fenton

Salary:

80000.00 - 90000.00 USD / Year

Strive Compounding Pharmacy

Expiration Date

Until further notice

Requirements

High School Diploma or GED
Minimum of five (5) years experience in a quality or manufacturing department within a pharmaceutical, medical device, or allied health science environment
Proven experience in aseptic operations and working in regulated environments
Strong knowledge of pharmaceutical quality assurance practices, including deviation management, CAPA, change control, and documentation review
Ability to analyze and interpret data, identify trends, and recommend preventive actions
Strong organizational, communication, and problem-solving skills
Proficiency with Microsoft Office Suite and quality management systems (QMS)

Job Responsibility

Supervise the site Quality Assurance team, including task assignment, workload prioritization, timecard management, performance reviews, coaching, and discipline as needed
Lead QA candidate interviews and oversee onboarding, training, and competency development
Conduct routine QA team meetings and cross-department quality huddles
Train QA personnel to ensure proficiency in documentation, review, and compliance expectations
Conduct regular reviews of compounding, production, and cleaning documentation (batch records, cleaning logs, inventory sheets) for accuracy and completeness
Verify and reconcile all labeling to ensure control and accountability
Review temperature monitoring and Building Management System (BMS) alarms to verify timely investigation and resolution
Confirm that product test results meet specifications prior to release
Review documentation for media fill and process validation activities
Approve equipment calibration, preventive maintenance, and certification records to ensure adherence to schedules and standards

What we offer

Employer paid healthcare coverage available after 30 days of employment
Choice of an FSA/HSA
Voucher for new hire scrubs (if applicable)
Parental leave
401(k) plan with matching contributions
Weekends and holidays off
FREE COMPOUNDED MEDS to employees and immediate family members

Fulltime

New

Pharmacist

Provides a quality level of comprehensive clinical pharmaceutical services demon...

Location

United States , Bakersfield

Salary:

69.41 - 103.25 USD / Hour

American Nursing Care

Expiration Date

Until further notice

Requirements

Current license as a registered Pharmacist in the State of California
BLS required
Bachelor of Science in Pharmacy or Doctor of Pharmacy degree

Job Responsibility

Provides a quality level of comprehensive clinical pharmaceutical services demonstrating sound judgment based upon knowledge and application of professional, departmental, and organizational principles and standards
Demonstrates an ability to coordinate subordinate activities by providing direction and guidance concerning the operational activities of the department
Demonstrates ability to document clinical activities and interventions such as consults, patient teachings and other patient specific information as defined by policy and procedure
Interprets medication orders and/or prescriptions for drug interactions, appropriate drug selection and appropriateness
Accurately enters / verifies the order or prescription into the computer system, labels, and dispenses medications in a timely manner
Verifies and checks medications prepared by other pharmacy personnel
Communicates drug information to patients and health professionals
Resolves drug related problems by consulting with other health care professionals to achieve appropriate patient outcomes
Unclear orders written by a licensed provider are clarified with the licensed provider
Assists the licensed provider in appropriate drug selection and therapeutic regimens

What we offer

medical
prescription drug
dental
vision plans
life insurance
paid time off
tuition reimbursement
retirement plan benefit(s) including, but not limited to, 401(k), 403(b), and other defined benefits offerings

Fulltime

New

Pharmacist

Provides a quality level of comprehensive clinical pharmaceutical services demon...

Location

United States , Bakersfield

Salary:

69.41 - 103.25 USD / Hour

American Nursing Care

Expiration Date

Until further notice

Requirements

Current license as a registered Pharmacist in the State of California
BLS required
Bachelor of Science in Pharmacy or Doctor of Pharmacy degree
Must possess strong knowledge of Pharmacy Services
Knowledgeable and skilled in current practice concepts of pharmacy practice settings
Strong knowledge of applicable laws, regulations, guidelines and professional standards
Strong project management skills
Good strategic planning skills
Strong change management skills
Must demonstrate personal traits of a high level of motivation, team orientation, professionalism, trust, and place a high value on treating others with dignity and respect.

Job Responsibility

Provides a quality level of comprehensive clinical pharmaceutical services demonstrating sound judgment based upon knowledge and application of professional, departmental, and organizational principles and standards
Demonstrates an ability to coordinate subordinate activities by providing direction and guidance concerning the operational activities of the department
Demonstrates ability to document clinical activities and interventions such as consults, patient teachings and other patient specific information as defined by policy and procedure
Interprets medication orders and/or prescriptions for drug interactions, appropriate drug selection and appropriateness
Accurately enters / verifies the order or prescription into the computer system, labels, and dispenses medications in a timely manner
Verifies and checks medications prepared by other pharmacy personnel
Communicates drug information to patients and health professionals
Resolves drug related problems by consulting with other health care professionals to achieve appropriate patient outcomes
Unclear orders written by a licensed provider are clarified with the licensed provider
Assists the licensed provider in appropriate drug selection and therapeutic regimens

What we offer

medical, prescription drug, dental, vision plans, life insurance, paid time off, tuition reimbursement, retirement plan benefit(s) including, but not limited to, 401(k), 403(b), and other defined benefits offerings

Fulltime

Director, Regulatory Labeling

Beam Therapeutics

Location:
United States , Cambridge

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
December 24, 2025

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