Top 474 Director of regulatory affairs Jobs in Massachusetts

Senior Director, Drug Safety & Pharmacovigilance – Development
Klein Hersh International —Boston, MA
- Email
- Medicine
- 5 years
- Contracts
Associate Director, Global Inspection Management
Ultragenyx Pharmaceutical —Bedford, MA
- $179,600 - $221,900 a year
- Hybrid work
- 11+ years
- Bachelor's degree
- Children
- Gym membership
Executive Medical Director, Oncology Clinical Sciences
Takeda Pharmaceutical —Boston, MA
- $286,900 - $450,890 a year
- Full-time
- Medicine
- 7 years
- Office
- Paid holidays
- Disability insurance
Director of Clinical Affairs - Ambulatory Monitoring and Diagnostics
Philips —Cambridge, MA
- $171,000 - $306,000 a year
- Full-time
- Office
- Bachelor's degree
- US work authorization
- Health savings account
- Employee stock purchase plan
Medical Director, Elms College Health Center (Independent Contractor)
Elms College —Chicopee, MA
- $13,000 a year
- Day shift
- Medicine
- Management
- University
Quick Apply
Senior Product Manager, Medical Device Aesthetics
Atrium —Marlborough, MA
- $145,000 - $195,000 a year
- Marketing
- Bachelor's degree
- Product management
- Vision insurance
Quick Apply
14d
Executive Director- Ambulatory Surgery Center
Healthcare Practice Solutions, Inc. —Springfield, MA
- $75,000 - $100,000 a year
- 8 hour shift
- Background check
- Microsoft Excel
- Surgery
- Flexible spending account
- Tuition reimbursement
Quick Apply
Director Security Engineering
Johnson Controls —Westford, MA
- $142,000 - $200,000 a year
- Full-time
- Computer Science
- 5 years
- Product management
- Paid holidays
- Health insurance
Quick Apply
4d
Senior Director, Quality Control
EPM Scientific —Boston, MA
- Contract
- Bachelor's degree
- Mentoring
- US work authorization
Quick Apply
Director, Government Legislative Affairs
Blue Cross Blue Shield of Massachusetts —Boston, MA
- $198,360 - $242,440 a year
- Full-time
- Hybrid work
- HIPAA
- 11+ years
- High school diploma or GED
- Health insurance
- Dental insurance
State & Local Government Affairs Director
Genentech —Boston, MA
- $159,900 - $296,900 a year
- Online Application
- Management
- Bachelor's degree
- Travel
Associate Director, Medical Affairs Operations & Strategy
Praxis Precision Medicines, Inc. —Boston, MA
- $170,000 - $195,000 a year
- Email
- Remote
- Bachelor's degree
- Travel
- Contracts
- AD&D insurance
- Employee stock purchase plan
Quick Apply
Director of State and Local Affairs, Northeast
JERA Co., Inc —Boston, MA
- Full-time
- Public speaking
- Master's degree
- Travel
Director, Privacy (Remote)
Cengage —Massachusetts
- $138,200 - $179,650 a year
- Full-time
- Remote
- Bachelor's degree
- Continuous improvement
- Mentoring
3d
US Cybersecurity and Customer Trust Director
Dassault Systèmes —Waltham, MA
- $210,000 - $250,000 a year
- Fair chance
- Senior level
- Leadership
- Paid holidays
- Disability insurance
Healthcare Compliance Operations Manager/ Senior Manager
Ionis Pharmaceuticals, Inc. —Boston, MA
- $72,800 - $129,967 a year
- Remote
- Analysis skills
- Bachelor's degree
- Travel
Quick Apply
Associate Director, Program Management Office
Alkermes, Inc. —Waltham, MA
- Full-time
- Hybrid work
- Psychiatry
- Bachelor's degree
- Neurology
Federal Policy & Municipal Affairs Director
Dana-Farber Cancer Institute —Brookline, MA
- $138,600 - $154,200 a year
- Full-time
- Hybrid work
- 5 years
- Office
- Master's degree
Associate Director, Competitive Intelligence & Market Research, Commercial Operations & Analytics
Agios Pharmaceuticals —Cambridge, MA
- $153,541 - $230,312 a year
- Remote
- 8 years
- Analysis skills
- Bachelor's degree
- Health insurance
Scientific Affairs Specialist
Bruker —Billerica, MA
- $85,000 - $153,500 a year
- Full-time
- Remote
- Up to 50% travel
- Driver's License
- Travel
- Employee stock purchase plan
- Disability insurance

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Senior Director, Drug Safety & Pharmacovigilance – Development

Klein Hersh International -
Boston, MA

Apply Now

Job Details

Qualifications

FDA submissions
Managerial strategic planning
Pharmacovigilance research
Adverse event reporting
Clinical trial risk management
Safety regulations
Lean
Investigational new drug (IND) applications
Supplier relationship improvement
ICH guidelines
Vendor compliance management
Pharmaceutical company experience
Vendor relationship management
Contracts
Vendor contract management
Regulatory submission editing and review
Communication with regulatory authorities for clinical trials
Clinical quality assurance standards
Oncology
Clinical program risk management
Cross-functional team management
Cross-functional communication
Senior leadership

Full Job Description

Contact: Kevin Mednick
Phone: (215) 658-1379

Position Overview

Our client is a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large patient populations, including those not addressed by existing platform technologies.

This role will serve as the safety expert across programs and drive safety excellence with the clinical development organization. In collaboration with internal and external partners, you will design and implement best-in-class safety practices to ensure global compliance, support health authority submissions, and protect patient well-being and safety.

Key Responsibilities:

Clinical Safety Leadership

Act as the drug safety lead for one or more clinical-stage assets, providing clinical oversight and proactive safety surveillance in collaboration with global program/clinical teams.
Design, direct and conduct ongoing safety surveillance of company drug products using internal and external resources (e.g. CROs/vendors) to ensure delivery of high-quality Drug Safety services, including oversight of patient safety in all ongoing clinical trials. This includes the medical review of (AEs) and Serious AEs (SAEs).
Provide strategic planning, implementation, and management of Drug Safety activities to support the clinical development of company products.
Serve as the clinical safety expert for all assigned products at all stages of clinical development. As needed, provide hands-on oversight of all clinical safety services including review of medical coding of AEs, concomitant medications, and processing of SAEs (review, query generation and resolution, and preparation of case narratives) through the entire lifecycle.
Establish and conduct signal management procedures including signal evaluation reports and recommendations for risk characterization.
Lead the Risk Management Team (RMT) meetings for review of safety data and AE profile, including production of any associated materials (e.g., aggregate reports, charter).
Provide medical review of AE reports to ensure the accuracy, integrity and completeness of information entered in the safety database.
Contribute critical medical input to clinical documents, including protocols, investigator brochures, and informed consents.
Review and approve safety data for regulatory submissions, aggregate safety reports (e.g., DSURs, PSURs/PBRERs, RMPs), and safety sections of CTD documents.
Provide medical expert safety review input for critical documents for clinical development of products (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs)

Function Building & Operational Oversight

Build and own the internal Drug Safety & PV function with a focus on scalability, agility, and regulatory excellence.
Oversee day-to-day Safety Operations via a partially outsourced model; manage and optimize PV vendor relationships.
Ensure the quality and timeliness of AE processing, safety database management, MedDRA coding, and global reporting.
Develop and maintain PV policies, SOPs, safety governance frameworks, and inspection readiness plans.

Strategic Collaboration & Influence

Serve as a key clinical safety representative on Clinical Study Teams and global program teams (as needed).
Partner closely with Clinical Development, Regulatory Affairs, Quality, and DMPK to align on safety strategies and data interpretations.
Support safety-related interactions with global health authorities, including preparation for and participation in regulatory meetings, inspections or audits.
Bring a solutions-oriented mindset to evolving internal processes and organizational needs as the company scales.

Key Requirements:

MD or equivalent medical degree required; specialty training in oncology.
Strong desire to be part of a mission‐oriented company leading transformative change for patients.
Proven demonstration of transparent communication and fostering open and diverse debate.
Ability to work with agility and manage ambiguity.
Personifies positive energy and exemplifies respect.
Outstanding interpersonal and communication skills, with the ability to foster trust, influence stakeholders, and operate cross-functionally.
A blend of strategic acumen and operational know-how, able to pivot between high-level planning and detailed execution.
5-7+ years of biopharmaceutical industry experience in pharmacovigilance and clinical safety, with demonstrated success in a leadership capacity.
Proven experience managing pharmaco-vigilance in a partially or fully outsourced model, including vendor oversight and contract management.
Expert knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; expertise in global safety regulations.
Expertise in clinical safety assessments, safety signal detection and risk management, including interactions with regulatory authorities
In-depth knowledge of global PV regulations and good pharmacovigilance practice requirements, with direct experience in INDs, NDAs/BLAs/MAAs, and other regulatory submissions.
A track record of building or scaling safety functions, especially in lean, high-growth environments.

Location: Boston/RTL/Remote

Location(s)

Boston, MA

If interested, please send a MS Word version of your resume to [email protected]

Apply Now

Refine Your Search

director of regulatory affairs jobs in massachusetts

Senior Director, Drug Safety & Pharmacovigilance – Development

Associate Director, Global Inspection Management

Executive Medical Director, Oncology Clinical Sciences

Director of Clinical Affairs - Ambulatory Monitoring and Diagnostics

Medical Director, Elms College Health Center (Independent Contractor)

Senior Product Manager, Medical Device Aesthetics

Executive Director- Ambulatory Surgery Center

Director Security Engineering

Senior Director, Quality Control

Director, Government Legislative Affairs

State & Local Government Affairs Director

Associate Director, Medical Affairs Operations & Strategy

Director of State and Local Affairs, Northeast

Director, Privacy (Remote)

US Cybersecurity and Customer Trust Director

Healthcare Compliance Operations Manager/ Senior Manager

Associate Director, Program Management Office

Federal Policy & Municipal Affairs Director

Associate Director, Competitive Intelligence & Market Research, Commercial Operations & Analytics

Scientific Affairs Specialist

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