734 Results for

Regulatory Affairs Jobs in Chestnut Hill, MA

Jobs

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.

4 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.

5 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.

7 days ago

Director, Global Regulatory Affairs, Neuroscience Takeda

Boston, Massachusetts

$177,000–$278,080 / year

Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible.

4 days ago

Global Regulatory Affairs Manager, Oncology GSK, Plc.

Waltham, MA

$138,750–$231,250 / year

GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. You will be accountable to the Global Regulatory Lead (GRL) and Global Regulatory Therapeutic Area (TA) Head and collaborate with cross-functional teams to shape development plans and regulatory interactions across multiple regions.

9 days ago

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.

10 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.

13 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.

13 days ago

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

Cambridge, MA

$175,000–$220,000 / year

14 days ago

Senior Manager, Regulatory Affairs, CMC Stoke Therapeutics, Inc.

Bedford, MA

$181,000–$213,000 / year

Position Purpose: The Regulatory CMC Senior 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.

9 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.

15 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.

16 days ago

Vice President, Regulatory Affairs Editas Medicine, Inc.

Cambridge, MA

$345,000–$372,000 / year

Reporting to the Chief Medical Officer, this hands-on leader will oversee all regulatory activities from development candidate selection through clinical development and marketing authorization, including leading interactions with global health authorities, authoring and managing submissions, establishing regulatory processes and systems, and shaping evidence-generation strategies for innovative gene editing products in an evolving regulatory landscape. Decoding The Role: The Vice President, Regulatory Affairs will lead and build the global regulatory function and strategy for a growing portfolio of in vivo gene editing therapies, serving as the company's primary regulatory expert and strategic advisor to executive leadership, program teams, the Board, and external partners.

16 days ago

Associate Director, Regulatory Affairs (IVD) Precede Biosciences Inc

Cambridge, MA

$175,000–$220,000 / year

14 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?

17 days ago

Spring 2027 Co-Op, Global Regulatory Affairs - Strategy And Operations Vertex Pharmaceuticals, Inc

Boston, MA

$30–$55 / hour

17 days ago

Senior Regulatory Affairs Coordinator Brigham and Women's Hospital

Somerville, MA

$50,502.40–$82,014.40 / year

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?

16 days ago

VP, Regulatory Affairs Prime Medicine, Inc.

Cambridge, MA

$313,000–$348,000 / year

Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies.

20 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.

6 days ago

VP, Regulatory Affairs Prime Medicine Inc

Cambridge, MA

$313,000–$348,000 / year

20 days ago

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Regulatory Affairs Jobs in Chestnut Hill, MA

Director, Regulatory Affairs CMC Madrigal Pharmaceuticals

Director, Regulatory Affairs Arbor

Associate Director, Regulatory Affairs (IVD) Precede

Director, Global Regulatory Affairs, Neuroscience Takeda

Global Regulatory Affairs Manager, Oncology GSK, Plc.

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

Senior Director, Regulatory Affairs CMC – Biologics Beeline Medicines

Senior Director, Regulatory Affairs CMC – Small Molecule Beeline Medicines

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

Senior Manager, Regulatory Affairs, CMC Stoke Therapeutics, Inc.

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

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

Vice President, Regulatory Affairs Editas Medicine, Inc.

Associate Director, Regulatory Affairs (IVD) Precede Biosciences Inc

Senior Regulatory Affairs Coordinator Mass General Brigham

Spring 2027 Co-Op, Global Regulatory Affairs - Strategy And Operations Vertex Pharmaceuticals, Inc

Senior Regulatory Affairs Coordinator Brigham and Women's Hospital

VP, Regulatory Affairs Prime Medicine, Inc.

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

VP, Regulatory Affairs Prime Medicine Inc

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