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Regulatory Affairs Jobs in Everett, MA

Jobs

Director, Global Regulatory Affairs Stoke Therapeutics, Inc.

Bedford, MA

$248,000–$280,000 / year

Position Purpose: The Director, Global Regulatory Strategy will be responsible for developing and delivering global regulatory strategies to ensure products are developed, approved, and maintained in compliance with health authority requirements and in alignment with the corporate strategy for Stoke's portfolio. Develops and maintains current regulatory knowledge and provides guidance to regulatory staff and company management; identifies the need for new or expanded regulatory policies, processes and SOPs, and approves and ensures implementation to establish a compliant culture.

10 days ago

Director, Global Regulatory Affairs CMC 3316 Takeda Development Center Americas

Boston, Massachusetts

This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows: Independently develops the regulatory CMC strategy and leads the execution of regulatory CMC investigational, registration and post-approval strategies for their assigned product(s) and may serve as the GRA CMC Product Lead, as required. Proactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in adequate and timely manner to cross-functional programs/ products teams and management level within GRA CMC, GRA, PS, GMS and QA - as appropriate.

3 days ago

Executive Director, Global Regulatory Affairs CMC Early Development 3316 Takeda Development Center Americas

Boston, Massachusetts

Accountable for ensuring global CMC content quality and compliance for early development submissions and lifecycle changes through Phase 2 (e.g., IND/CTA modules, IMPD quality sections, amendments, investigator’s brochure CMC, and responses to health authority questions), partnering with regional leads and technical functions to ensure consistent, inspection-ready documentation. Represents Global Regulatory Affairs CMC in senior-level governance and in interactions with global health authorities, including FDA, EMA, MHRA, PMDA, and other agencies as applicable, to enable efficient pathways for early development CMC strategies and submissions (e.g., pre-IND/IND/CTA, amendments, Type B/C meetings, scientific advice).

3 days ago

Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product 3316 Takeda Development Center Americas

Boston, Massachusetts

As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product, you will provide strategic leadership and development to global regulatory subject matter experts to ensure innovative and robust regulatory strategies for medical devices and drug-device combination products, maximizing global regulatory success and minimizing time to approval/clearance. Leads and develops a team of regulatory leaders and subject matter experts, overseeing global regulatory strategy and major submissions for an assigned portfolio of medical devices and drug-device combination products, ensuring clear strategy, high-quality execution, and timely approvals/clearances.

3 days ago

VP Or Svp, Regulatory Affairs Acrivon Therapeutics Inc.

Watertown, MA

These distinctive capabilities enable the company to go beyond the limitations of traditional drug discovery, as well as current AI-based target-centric drug discovery and rapidly design highly differentiated compounds with desirable pathway effects through intracellular protein network analyses and advance these agents into the clinic for streamlined development. Acrivon is currently advancing its lead program, ACR-368 (also known as prexasertib), a selective small molecule inhibitor targeting CHK1 and CHK2 in a potentially registrational Phase 2 trial for endometrial cancer.

30+ days ago

Associate Director, Regulatory Affairs CMC CRISPR Therapeutics AG

South Boston, MA

$165,000–$180,000 / year

The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY (exagamglogene autotemcel [exa-cel]), the world's first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. You will work in close collaboration with CMC and global development teams, and with relevant external parties including contract manufacturing organizations, expert consultants, development partners, and global health authorities.

30+ days ago

Vice President, Regulatory Affairs Rhythm Pharmaceuticals

Boston, MA

$260,000–$360,000 / year

This leader will oversee a geographically diverse team responsible for execution of international regulatory affairs, regulatory operations, regulatory business operations, labeling, and CMC regulatory, while partnering closely with global regulatory strategy and cross-functional teams. Proven operational leadership with urgency and discipline, including experience leading high-performing teams, team leaders, and subject matter experts through growth, change, and increasing organizational complexity.

30+ days ago

Senior Regulatory Affairs Specialist Philips

Cambridge, MA

$99,000–$157,000 / year

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. Lead global regulatory intelligence initiatives, contribute to regulatory and product registration strategies, and help implement global regulatory roadmaps based on the competitive landscape and marketing objectives.

30+ days ago

Manager, Regulatory Affairs Collegium Pharmaceutical

Stoughton, MA

$132,219–$158,400 / year

Manage labeling for approved and investigational products, including U.S. prescribing information, clinical trial labeling, and packaging components, while coordinating cross-functional reviews to ensure regulatory compliance, accuracy, and consistency throughout the product lifecycle. They will work in a highly cross-functional manner with internal stakeholders including Medical, Commercial, Legal and Compliance, and Technical Operations to file and maintain the applications for Collegium's marketed products and development programs in compliance with applicable regulations.

30+ days ago

Director, Government Legislative Affairs BlueCross and BlueShield of Massachusetts

Boston, MA

$198,360–$242,440 / year

Directly advocate for the Company's interests in legislative hearings, regulatory sessions, and one-on-one meetings with legislators, regulators, and staff on issues impacting health care and the insurance industry, including behavioral health and substance use disorder treatment, prescription drug pricing and transparency policy, provider payment policy, municipal health reform, and utilization management tools. In-depth demonstrated knowledge and understanding of the health care and health insurance industry, including specific issue-area expertise in public policy related to behavioral health, substance use disorder, prescription drug pricing and transparency policy, provider payment policy, municipal health reform, and utilization management tools.

30+ days ago

Senior Manager, Strategy - Medical Affairs Azurity Pharmaceuticals

Woburn, MA

Remote

Medical Affairs at Azurity Pharmaceuticals, a privately held company delivering innovative medicines for overlooked patients across 50+ countries, drives scientific and clinical initiatives with a portfolio of 30+ brands spanning 10 dosage forms and 9 therapeutic areas. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline.

19 days ago

Director Of Clinical Affairs - Ambulatory Monitoring And Diagnostics Philips

Cambridge, MA

$171,000–$273,000 / year

Experience with ambulatory monitoring (Holter and/or Mobile Cardiac Output Telemetry (MCOT)), remote patient management, advanced algorithms including AI and/or predictive analytics using electrocardiographic or similar devices along with the ability to represent Philips professionally in scientific, regulatory, clinical, and business forums and travel domestically and internationally approximately 20-30% of the time. You're the right fit if: You've acquired 10+ years of directly related clinical or scientific experience, including leadership or management experience within the medical device industry, and 5+ years managing a clinical research functional team with a proven track record delivering complex clinical programs on time, within budget, and in compliance with applicable requirements.

30+ days ago

Medical Affairs Lead Hemab ApS

Cambridge, MA

Youll translate the biology of the coagulation cascade into the medical narrative that shapes how clinicians, investigators, payers, and patients understand the disease, and carry an assets evidence and engagement plan from late-stage development through launch. Architect the evidence-generation roadmap with Clinical Development, Market Access, and Biostatistics, spanning natural history registries (GT360, VWD360, FVIID360), real-world evidence, and post-approval commitments.

4 days ago

Director, Clinical Affairs Of Coronary/Vascular Philips

Bedford, MA

$171,000–$273,000 / year

You're the right fit if: You've acquired 10+ years of directly related clinical or scientific experience, including leadership or management experience within the medical device industry, and 5+ years managing a clinical research functional team with a proven track record delivering complex clinical programs on time, within budget, and in compliance with applicable requirements. Your skills include comprehensive knowledge of clinical research regulations across multiple regions, FDA medical device regulations, medical device clinical trial practices, Good Clinical Practice, informed consent requirements, regulatory documentation, and the clinical evidence requirements needed to support regulatory, product development, and commercial objectives.

24 days ago

Director/ Senior Director, Regulatory Strategy (Pediatrics) Agios Pharmaceuticals

Cambridge, MA

$229,562–$344,342 / year

Plan and lead health authority interactions, as needed, including the development and/or review of associated documents Engage with Regulatory Authorities on project-related matters Ensure adherence to current regulations associated with regulatory activities Develop and provide oversight of direct report(s) within the regulatory strategy team What you bring: Bachelor's degree in life-sciences or related scientific discipline required; advanced degree (PhD, PharmD, or MS) preferred Director: 10+ years of experience in Regulatory Affairs within the biopharmaceutical industry Sr Director: 15+ years of experience in Regulatory Affairs within the biopharmaceutical industry 7+ years of experience with pediatric plans (both in US and EU) Experience leading preparations for health authority interactions and development of briefing documents Strong knowledge of drug development, FDA, EMA and ICH guidelines and regulations Excellent organizational and communication skills, both written and verbal Ability to work independently as well as part of a team environment Positive attitude, energetic and proactive Proven ability to manage multiple projects, identify and resolve regulatory issues Strong interpersonal skills and the ability to effectively work with others Experience managing individuals Concerned that you don't check off every box in the requirements listed above? What you will do: Develop and execute global regulatory strategy for pediatric development as well as potential business development opportunities, including the potential to accommodate expedited development needs Provide global regulatory expertise in support of the development, review, and approval of cross-functionally developed strategies and documents intended to enable clinical trials and marketing authorizations for pediatric programs.

30+ days ago

Director, Regulatory CMC Rhythm Pharmaceuticals

Boston, MA

$182,000–$275,000 / year

As part of the growing and dynamic regulatory affairs team, this role is accountable for the effective management and timely delivery of CMC regulatory documents, coordination of cross-functional inputs, and support of regulatory CMC execution activities across development, commercialization, and lifecycle management. Author, compile, review, and finalize high-quality CMC regulatory documents and submissions, including core dossiers, INDs, IMPDs, MAAs, BLAs, variations, and annual reports, in collaboration with internal and external stakeholders.

30+ days ago

Director, Quality & Regulatory- Mergers & Acquisitions (M&A) Philips

Cambridge, MA

$181,000–$288,000 / year

Ensure successful transition and exit of transition services, including full transfer of Q&R responsibilities and retirement of TSLA obligations prior to completion of Day 2. You're the right fit if: You have a minimum of 15+ years' experience in FDA regulated global medical device environments (Class III products/devices preferred) with demonstrated experience/expertise in cross-functional Program leadership/management, focused on Quality/regulatory compliance, change management and M&A within global/matrixed medical device organizations. The Director, Quality & Regulatory M&A is an enterprise Q&R leader for M&A activities and primary interface to deal teams, providing end-to-end leadership across the transaction lifecycle, with a focus on complex divestitures, carve-outs, and separations.

30+ days ago

Head Of Regulatory, AM & D Philips

Cambridge, MA

$171,000–$273,000 / year

Partner cross-functionally to integrate regulatory requirements into product development and business processes, leading regulatory planning, risk assessments, and compliance strategies while driving continuous improvement initiatives that enhance operational efficiency, quality, and regulatory outcomes. Drive regulatory compliance and market access across the product lifecycle, overseeing global product registrations, approvals, CE Marking, clinical evaluations, regulatory submissions, and change management activities to ensure timely commercialization and sustained compliance in international markets.

25 days ago

Associate Director GRA CMC SaMD & Cybersecurity Specialist CSL Plasma

Waltham, Pennsylvania

Author, review, and ensure delivery of high-quality regulatory documentation—including 510(k), De Novo, PMAs, Q-Submissions/Pre-Submissions (Pre-IND, Pre-BLA), BLAs/sBLAs, MAAs, CTAs, INDs, DHFs, CE technical documentation, international device registrations, post-approval supplements and variations, MAFs, LOAs, technical files, CERs, PMCF documentation, and related briefing packages—in accordance with applicable US, EU, ISO, IEC, and IMDRF requirements. In-depth knowledge of global device regulatory requirements, including but not limited to: EU MDR, ISO 13485, ISO 14971, ISO 15223, ISO 10993, IEC 62366, IEC 62304, IEC 60601, ISO 20916, ISO 18113, ISO 23640, 21 CFR Part 820, IEC 62304:2006, ISO 14971:2019, IEC/TR 80002-1:2009, IMDRF Software as a Medical Device Framework, QSR and BIMO compliance, and PFSB/MDRMPED for SaMD.

4 days ago

VP of Drug Safety/Pharmacovigilance Compass Therapeutics

Boston, MA

$325,000–$450,000 / year

Provide executive oversight and review of safety-related regulatory submissions, cross functionally collaborating with Clinical, Medical, Quality, and Regulatory, including DSURs, DCSI, Risk Management Plans, Investigator Brochures, Clinical Study Report, Informed Consent Forms (ICFs), protocols, reports, other required safety documentation in accordance with legal requirements, respective SOPs and Health Authority. Ensure patient safety by monitoring patient safety profiles to identify and mitigate potential risks associated with Compass drugs; recommend updates to Development Core Safety Information (DCSI)/Reference Safety Information, communicate risks to applicable stakeholders.

17 days ago

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Regulatory Affairs Jobs in Everett, MA

Director, Global Regulatory Affairs Stoke Therapeutics, Inc.

Director, Global Regulatory Affairs CMC 3316 Takeda Development Center Americas

Executive Director, Global Regulatory Affairs CMC Early Development 3316 Takeda Development Center Americas

Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product 3316 Takeda Development Center Americas

VP Or Svp, Regulatory Affairs Acrivon Therapeutics Inc.

Associate Director, Regulatory Affairs CMC CRISPR Therapeutics AG

Vice President, Regulatory Affairs Rhythm Pharmaceuticals

Senior Regulatory Affairs Specialist Philips

Manager, Regulatory Affairs Collegium Pharmaceutical

Director, Government Legislative Affairs BlueCross and BlueShield of Massachusetts

Senior Manager, Strategy - Medical Affairs Azurity Pharmaceuticals

Director Of Clinical Affairs - Ambulatory Monitoring And Diagnostics Philips

Medical Affairs Lead Hemab ApS

Director, Clinical Affairs Of Coronary/Vascular Philips

Director/ Senior Director, Regulatory Strategy (Pediatrics) Agios Pharmaceuticals

Director, Regulatory CMC Rhythm Pharmaceuticals

Director, Quality & Regulatory- Mergers & Acquisitions (M&A) Philips

Head Of Regulatory, AM & D Philips

Associate Director GRA CMC SaMD & Cybersecurity Specialist CSL Plasma

VP of Drug Safety/Pharmacovigilance Compass Therapeutics

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