1,783 Results for

Regulatory Affairs Jobs in Winthrop, MA

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Associate Director, CMC Regulatory Affairs Vertex Pharmaceuticals, Inc

Boston, MA

$166,400–$249,600 / year

We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients. This role also provides regulatory guidance to various cross-functional teams and ensures all applicable global regulatory requirements are considered and appropriately incorporated into investigational and commercial products.

5 days ago

Manager Regulatory Affairs Advertising and Promotion Sanofi

Cambridge, MA

$122,250–$176,583.33 / year

Provides product-specific Regulatory strategies to mitigate risk; works in conjunction with brand team management to provide advice and risk/benefit analysis to maximize value to stakeholders. Identifies different strategies for addressing issues; advises of risk/benefit of each and assists clients with making sound business decisions with the understanding of the potential risk/benefits with respect to intervening regulatory matters.

6 days ago

Manager Regulatory Affairs Advertising And Promotion Sanofi

Cambridge, MA

$122,250–$176,583.33 / year

6 days ago

Vice President, US Regulatory Affairs ITF Therapeutics

Concord, Massachusetts

$330,000–$370,000 / year

The Vice President of Regulatory Affairs is a senior leadership role responsible for leading and developing all US regulatory activities for ITF Therapeutics’ rare disease portfolio, including both marketed and pipeline products. Provide expert Regulatory and Pharmacovigilance leadership across product development stages and translate regulatory context into actionable business strategies that optimize impact for the patient communities we serve.

3 days ago

Director, Regulatory Affairs CMC Summit Therapeutics Inc

Cambridge, MA

$190,000–$237,000 / year

HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. This role will manage regulatory CMC aspects of compounds (large molecules) through all phases of development and provide strategic and operational management of preparation and maintenance of CMC regulatory filings to support ongoing clinical activities as well as marketing applications.

6 days ago

Manager, Regulatory Affairs, CMC Stoke Therapeutics Inc

Bedford, MA

$145,000–$160,000 / year

Position Purpose: The Regulatory CMC Manager is responsible for contributing to the development of Stoke's products by supporting global CMC regulatory strategies, leading lifecycle management initiatives, and providing regulatory guidance to cross-functional teams for multiple programs. Key Responsibilities: Prepares and executes global regulatory CMC strategy for development programs and future commercial programs, including new applications, information amendments, annual reports, supplements/ variations, and responses to health authority questions.

7 days ago

Manager, Regulatory Affairs, CMC Stoke Therapeutics, Inc.

Bedford, MA

$145,000–$160,000 / year

7 days ago

Manager, Regulatory Affairs Deciphera Pharmaceuticals Inc

Waltham, MA

$116,000–$160,000 / year

ROMVIMZA (vimseltinib) is a kinase inhibitor approved in the United States for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity, and in the European Union for adult patients with TGCT associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability. In addition to advancing multiple product candidates from Deciphera's platform in clinical studies, QINLOCK (ripretinib) is Deciphera's switch-control kinase inhibitor approved in many countries including the European Union and the United States for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

6 days ago

Director, Regulatory Affairs Arbor

Cambridge, Massachusetts

$215,000–$235,000 / year

Lead cross‑functional planning of regulatory submissions and amendments, including IND submissions to FDA, and provide regulatory oversight of CRO‑led regulatory activities and submissions outside the United States. The Director of Regulatory Affairs is responsible for leading regulatory strategy and execution for Abror’s development programs across the portfolio, spanning preclinical and early clinical stages.

10 days ago

Associate Director, Regulatory Affairs (IVD) Precede

Cambridge, Massachusetts

$175,000–$220,000 / year

Author, compile, and drive high-quality submissions and responses, including FDA Pre-Submissions, IDEs, 510(k)s, De Novo requests, PMAs and supplements, and relevant international technical documentation (e.g. in support of IVDR CE). Precede Biosciences is seeking a hands-on Associate Director of Regulatory Affairs to lead regulatory strategy and execution for our products and companion diagnostic programs developed with biopharma partners.

12 days ago

Associate Director Regulatory Affairs – Vascular (on-site) Abbott

Westford, Massachusetts

$129,300–$258,700 / year

Lead regulatory strategy for on-market and sustaining activities, including product changes, regulatory impact assessments, maintenance of existing registrations/approvals, and other post-market regulatory activities throughout the product lifecycle. Maintain expert working knowledge of laws, regulations and enforcement decisions related to Quality Assurance (QA), manufacturing and Research & Development (R&D) issues that may impact company operations and decision making; communicate such knowledge to all internal stakeholders.

3 days ago

Director, Regulatory Affairs CMC Madrigal Pharmaceuticals

Waltham, Massachusetts

$207,000–$253,000 / year

The Director of Regulatory Affairs CMC provides strategic, tactical and operational regulatory CMC leadership to support clinical trial applications, market registrations and post-approval submissions, along with managing the day-to-day regulatory CMC activities of assigned projects for development and/or commercial products. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process.

9 days ago

Spring 2027 Co-op, Global Regulatory Affairs - Strategy and Operations Vertex Pharmaceuticals Inc

Boston, MA

$30–$55 / hour

For the reports and activities that occur on a set cadence - quarterly off-site meetings, goals progress, organizational changes and new starters/leavers (announcements, org charts), hiring updates, organizational health - automate updates, including mechanisms for collecting or implementing inputs with scheduled, tracked workflows that can be adjusted in real time. Transition Support: Work in close collaboration with Chief of Staff to support an active key transition project within GRA, through involvement in developing work products/plans, tracking key milestones, and building content to support integration activities, as needed.

21 days ago

Regulatory Affairs Manager Nova Biomedical

Waltham, MA

$145,000–$185,000 / year
Quick Apply

The Regulatory Affairs Manager is responsible for developing and executing global regulatory strategies supporting in vitro diagnostic (IVD) test systems, and other product portfolios throughout the product lifecycle, with primary emphasis on leading pre-market product development, market authorization submissions, and ongoing regulatory maintenance activities. This position serves as a regulatory leader and business partner to Research & Development, Quality, Clinical Affairs, Marketing, Manufacturing, and Senior Functional Leadership to ensure products are developed, registered, and maintained in compliance with applicable global regulations.

Today

Sr. Regulatory Affairs Specialist - Recall and Post-Market Compliance (Hybird/Remote) Illumina Inc

Remote

$90,000–$135,000 / year

Key responsibilities include conducting timely assessments of potential adverse events and field actions to determine regulatory reportability, supporting MDR and recall decision-making, coordinating regulatory reporting activities, developing regulatory justifications and documentation, and ensuring compliance with applicable global regulations. The Senior Regulatory Affairs Specialist will be an instrumental member of the Regulatory Affairs team supporting on-market in vitro diagnostic (IVD) products in the United States and international markets.

15 days ago

Associate Director, Regulatory Affairs (Ivd) Precede Biosciences, Inc.

Cambridge, MA

$175,000–$220,000 / year

19 days ago

Spring 2027 Co-op, Global Regulatory Affairs – Strategy and Operations Vertex Pharmaceuticals

Boston, Massachusetts

$30–$55 / hour

For the reports and activities that occur on a set cadence – quarterly off-site meetings, goals progress, organizational changes and new starters/leavers (announcements, org charts), hiring updates, organizational health - automate updates, including mechanisms for collecting or implementing inputs with scheduled, tracked workflows that can be adjusted in real time. Transition Support: Work in close collaboration with Chief of Staff to support an active key transition project within GRA, through involvement in developing work products/plans, tracking key milestones, and building content to support integration activities, as needed.

20 days ago

Senior Director, Regulatory Affairs CMC – Biologics Beeline Medicines

Cambridge, Massachusetts

$242,000–$313,500 / year

Demonstrate entrepreneurial drive and resourcefulness in executing CMC regulatory responsibilities — proactively seek out information, build relationships across the CMC organization, and find creative avenues to get things done; a successful CMC regulatory lead takes ownership of being plugged in, earns trust within the team, and removes barriers through initiative and ownership. Act as a fully integrated partner within the CMC team, attending key technical meetings, engaging daily with Process Development, Analytical, Manufacturing Sciences, Drug Supply and Quality colleagues, and translating regulatory strategy into practical guidance that enables the CMC team to make informed decisions and move programs forward with regulatory confidence.

18 days ago

Senior Director, Regulatory Affairs CMC – Small Molecule Beeline Medicines

Cambridge, Massachusetts

$242,000–$313,500 / year

Act as a fully integrated partner within the CMC team, attending key technical meetings, engaging daily with Process Development, Analytical, Manufacturing Sciences, Drug Supply and Quality colleagues, and translating regulatory strategy into practical guidance that enables the CMC team to make informed decisions and move programs forward with regulatory confidence. Demonstrate entrepreneurial drive and resourcefulness in executing CMC regulatory responsibilities — proactively seek out information, build relationships across the CMC organization, and find creative avenues to get things done; a successful CMC regulatory lead takes ownership of being plugged in, earns trust within the team, and removes barriers through initiative and ownership.

18 days ago

Senior Regulatory Affairs Coordinator Mass General Brigham

Somerville, Massachusetts

Working closely with McCance Center leadership, faculty investigators, study teams, Institutional Review Boards (IRBs), regulatory agencies, participating research sites, MGB teams, and collaborating institutions, the successful candidate will provide regulatory guidance, coordination, and leadership; navigate complex regulatory processes; develop regulatory operations and procedures; and train and mentor staff on requirements and best practices. Education Bachelor's Degree Healthcare Management required or Bachelor's Degree Related Field of Study required or Master's Degree Related Field of Study preferred Can this role accept experience in lieu of a degree?

22 days ago

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Regulatory Affairs Jobs in Winthrop, MA

Associate Director, CMC Regulatory Affairs Vertex Pharmaceuticals, Inc

Manager Regulatory Affairs Advertising and Promotion Sanofi

Manager Regulatory Affairs Advertising And Promotion Sanofi

Vice President, US Regulatory Affairs ITF Therapeutics

Director, Regulatory Affairs CMC Summit Therapeutics Inc

Manager, Regulatory Affairs, CMC Stoke Therapeutics Inc

Manager, Regulatory Affairs, CMC Stoke Therapeutics, Inc.

Manager, Regulatory Affairs Deciphera Pharmaceuticals Inc

Director, Regulatory Affairs Arbor

Associate Director, Regulatory Affairs (IVD) Precede

Associate Director Regulatory Affairs – Vascular (on-site) Abbott

Director, Regulatory Affairs CMC Madrigal Pharmaceuticals

Spring 2027 Co-op, Global Regulatory Affairs - Strategy and Operations Vertex Pharmaceuticals Inc

Regulatory Affairs Manager Nova Biomedical

Sr. Regulatory Affairs Specialist - Recall and Post-Market Compliance (Hybird/Remote) Illumina Inc

Associate Director, Regulatory Affairs (Ivd) Precede Biosciences, Inc.

Spring 2027 Co-op, Global Regulatory Affairs – Strategy and Operations Vertex Pharmaceuticals

Senior Director, Regulatory Affairs CMC – Biologics Beeline Medicines

Senior Director, Regulatory Affairs CMC – Small Molecule Beeline Medicines

Senior Regulatory Affairs Coordinator Mass General Brigham

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