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Regulatory Affairs Jobs in Belmont, MA

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Medical Affairs/Safety - Associate Director, Patient Advocacy and Engagement - Contract TalentBurst, Inc.

Cambridge, MA

$60–$83.74 / hour
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The Associate Director, Patient Advocacy and Engagement, Rare and Pipeline will play a critical role in driving patient-centric strategies and strengthening relationships with patient advocacy organizations primarily in US. Develop initiatives to enhance disease awareness and improve time to diagnosis, as well as educate the patient community so that they are empowered to actively engage with their healthcare provider in the management of their disease.

2 days ago

Medical Science Liaison, Hematology - Northeast Jazz Pharmaceuticals

Boston, MA

Remote

$160,000–$240,000 / year
Quick Apply

The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. Consistently acts to enhance Jazz Pharmaceuticals’ image as an advocate of medical advancement by using knowledge of product, disease state and pipeline products to engage healthcare providers in meaningful scientific exchange of information.

2 days ago

Research Aggregate Reports Specialist - Contract TalentBurst, Inc.

Cambridge, MA

$90–$96.77 / hour
Quick Apply

Collaborates proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problems in specific therapeutic areas. Contribute to activities related to the functioning of Alnylam safety committees, including but not limited to, preparing reports, minutes and meeting documents; ensuring completion of action items; and participating in the discussion of patient safety issues.

2 days ago

US_Drug Safety Consultant II - Contract TalentBurst, Inc.

Cambridge, MA

$79.61 / hour
Quick Apply

Position Summary The PV Aggregate Reports Scientist is part of the Safety Surveillance and Aggregate (SSA) Reports team and is responsible for managing the processes for all aggregate reports (PSURs, DSURs, PADERs, and local reports). Schedule & Regulatory Oversight: Support the Aggregate Reports Master Schedule (production, updates, stakeholder reviews), conduct worldwide legislation reviews for aggregate reporting, and provide impact assessments.

2 days ago

Director, Global Trade Waters Corporation

Milford, MA

The Director, Global Trade Compliance & Trade Operations is a senior enterprise leader responsible for defining and advancing the company’s global trade strategy, integrating regulatory compliance with world-class import/export operations. This role operates at the intersection of risk governance and supply chain execution, ensuring the organization can scale globally while maintaining strict adherence to international trade laws.

23 days ago

Principal Market Development Manager - Environmental and Materials Science Waters Corporation

Milford, MA

Partner with corporate marketing and field sales teams to implement regionally relevant marketing campaigns, demand generation initiatives (seminars, webinars, user meetings, customer visits) and strategic messaging. The role spans the Waters total portfolio including instruments, consumables and application-specific offerings with a focus on environmental and materials science testing, regulatory compliance, and sustainability-driven market trends.

23 days ago

Associate Director, Regulatory Affairs Seaport Therapeutics

Boston, Massachusetts

Support Phase II PoC & Phase III Readiness; Develop Phase II protocols with Go/No-Go criteria and strategies to de-risk psychiatry/neurology programs; Prepare Phase III regulatory groundwork, including End-of-Phase II (EOP2) meeting packages, safety database planning, and alignment with ICH guidelines for multi-regional trials. Design integrated early development strategic plans that bridge preclinical data (toxicology, pharmacology, CMC) with Phase I/II clinical objectives, addressing unique psychiatry/neurology challenges (e.g., blood-brain barrier delivery, placebo response mitigation).

7 days ago

Senior Regulatory Affairs Specialist Boston Scientific

Marlborough, MA

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Your responsibilities will include: Reviews change notifications and performs regulatory impact assessment for product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings, and supports associated global submissions as needed.

5 days ago

Associate Director, Regulatory Affairs Parabilis Medicines

Cambridge, MA

$170,000–$195,000 / year

We are fiercely independent as a leader in defying the limitations of current therapeutic modalities, and interdependent as a team as we work collaboratively to shift drug discovery paradigms and provide patients with better treatment options. Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking biologically important targets long considered undruggable.

30+ days ago

Senior Director, Regulatory Affairs CMC – Small Molecule Beeline Medicines

Cambridge, Massachusetts

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.

30+ days ago

Senior Manager, Regulatory Affairs Azurity Pharmaceuticals - US

Woburn, MA

As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Manager will be responsible for overseeing and managing the regulatory activities for assigned products/projects and will serve as the regulatory representative on cross-functional teams for assigned projects. 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.

30+ days ago

Principal Regulatory Affairs Specialist Boston Scientific

Marlborough, MA

Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review. The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role.

30+ 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.

9 days ago

Consultant II, Regulatory Affairs Advertising and Promotion Syner-G

Boston, MA

Remote

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. The Consultant II serves as a key regulatory partner to Commercial, Medical, Legal, and Global Regulatory teams, enabling timely and compliant execution of brand strategy across product launch and lifecycle activities.

30+ days ago

Manager, Regulatory Affairs Deciphera

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.

30+ days ago

Manager, Regulatory Affairs Deciphera Pharmaceuticals

Waltham, Massachusetts

$116,000–$160,000 / year
Full time

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.

1 day ago

Head of Regulatory Affairs TRIMAREN

Watertown, MA

In partnership with Research, Clinical Development, CMC, Quality, and senior leadership, you will help ensure regulatory decisions are grounded in rigorous science, aligned with global expectations, and positioned to support accelerated development for transformative therapies. Lead preparation, review, and submission of high-quality regulatory documents, including IND/CTA amendments, briefing packages, meeting requests, annual reports, and related agency correspondence.

13 days ago

Regulatory Affairs Specialist II Boston Scientific

Marlborough, MA

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. The role will also develop regulatory strategies and provide support for new business development efforts involving external manufacturers, including original equipment manufacturers (OEMs) and contract manufacturers.

30+ days ago

Director or Senior Director, Regulatory Affairs Kymera Therapeutics

Watertown, MA

$195,000–$330,000 / year

Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Act as the global regulatory strategy lead for Kymera's IRF5 degrader program, developing and driving the overall program regulatory strategy across multiple immunology and inflammation (I/I) indications.

30+ days ago

Director, Regulatory Affairs CMC Vertex Pharmaceuticals Inc

Boston, MA

$190,400–$285,600 / year

General Summary: The Director, Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team responsible for developing and executing global regulatory strategies across multiple investigational and commercial products in the small molecule portfolio. This role provides strategic leadership for complex regulatory CMC activities, oversees Health Authority engagement, and ensures regulatory requirements are effectively integrated into development and commercialization plans.

30+ days ago

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Regulatory Affairs Jobs in Belmont, MA

Medical Affairs/Safety - Associate Director, Patient Advocacy and Engagement - Contract TalentBurst, Inc.

Medical Science Liaison, Hematology - Northeast Jazz Pharmaceuticals

Research Aggregate Reports Specialist - Contract TalentBurst, Inc.

US_Drug Safety Consultant II - Contract TalentBurst, Inc.

Director, Global Trade Waters Corporation

Principal Market Development Manager - Environmental and Materials Science Waters Corporation

Associate Director, Regulatory Affairs Seaport Therapeutics

Senior Regulatory Affairs Specialist Boston Scientific

Associate Director, Regulatory Affairs Parabilis Medicines

Senior Director, Regulatory Affairs CMC – Small Molecule Beeline Medicines

Senior Manager, Regulatory Affairs Azurity Pharmaceuticals - US

Principal Regulatory Affairs Specialist Boston Scientific

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

Consultant II, Regulatory Affairs Advertising and Promotion Syner-G

Manager, Regulatory Affairs Deciphera

Manager, Regulatory Affairs Deciphera Pharmaceuticals

Head of Regulatory Affairs TRIMAREN

Regulatory Affairs Specialist II Boston Scientific

Director or Senior Director, Regulatory Affairs Kymera Therapeutics

Director, Regulatory Affairs CMC Vertex Pharmaceuticals Inc

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