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Regulatory Affairs Jobs in Somerville, MA

Jobs

Medical Programs Specialist Foundation Medical Staffing

Boston, MA

$71,600–$89,500 / year

This role supports relationships and activities both internally and externally, partnering closely with cross-functional teams across FMI as well as external healthcare providers, consultants, and vendors. Preferred Qualifications: Experience using software platforms such as Microsoft Office Suite (Excel, PowerPoint, Word, Copilot, SharePoint), Smartsheet, and collaboration tools (e.g., Lucid, Slack, Showpad).

6 days ago

Head Of US Field Excellence Biogen Idec

Cambridge, MA

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. About This Role: As the Head of Commercial Field Excellence, you will lead multiple teams dedicated to the strategic alignment, planning, training, and effectiveness of Commercial Excellence across Biogen's North America Portfolio.

30+ days ago

Director, Brand Insights & Competitive Intelligence ITF Therapeutics

Concord, Massachusetts

$230,000–$250,000 / year

The Director, Brand Insights & Competitive Intelligence will lead the development of market insights and competitive intelligence to support a Phase III asset preparing for launch in the neurometabolic therapeutic area. Direct intelligence-gathering activities at key scientific congresses and industry meetings, collaborating with cross-functional teams to identify business-critical insights.

5 days ago

Director, Global Compliance Zenas BioPharma

Waltham, MA

$180,000–$226,051 / year

Zenas' earlier stage programs include ZB021, a clinical-stage, potentially best-in-class, oral, IL-17AA/AF inhibitor; ZB022, a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor; and ZB014, a preclinical half-life extended anti-CD-19 and FcRIIb monoclonal antibody. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases.

30+ days ago

Regional Sales Manager, Immunology - New York Metro Region, NY Galderma Group AG

Boston, MA

$187,000–$198,000 / year

Collaborate to understand the integrity of the use of Galderma Market/Patient Access and Field Reimbursement programs: including but not limited adherence programs and providing education to HCP's regarding the intent and appropriate use of Galderma's patient access and reimbursement programs. 3+ years in Sales Leadership Role; demonstrated successful history of field force management; Ability to lead and manage direct reports, establishing clear expectations, providing coaching, feedback, and assessing and evaluating performance.

9 days ago

Pioneer GMP Pipeline (Nationwide) Pioneer GMP Consulting

Newton, Massachusetts

Locations: Multiple U.S. Locations Work Arrangements: Remote, Hybrid, and Onsite Opportunities Schedules: Full-Time, Part-Time, and Project-Based Opportunities May Be Available Travel: Varies by Client Engagement | Willingness to Travel is Important Employment Classification: Confirmed for Each Opportunity Opportunity Status: Current and Future Consulting Needs Candidate Deck: Joining Pioneer GMP Consulting About the Opportunity. Our consultants work as embedded partners within pharmaceutical, biotechnology, cosmetic, dietary-supplement, medical-device, and CDMO organizations to solve complex problems, complete critical work, and strengthen regulated operations.

30+ days ago

Material Qualification Engineer LanceSoft Inc

Lexington, MA

$75–$77.70 / hour
Quick Apply

The person in this role will be instrumental in working with other members of the Quality Assurance, Quality Control, Supplier Quality, Supply Chain, Manufacturing and Engineering organizations to develop and execute MQ studies and projects to enhance the manufacturing systems and processes to compliantly and efficiently achieve organizational goals. Essential: Bachelor's in Material Science, Mechanical, Biomedical or Chemical Engineering or related science or engineering field with a minimum of 4 years relevant experience or Master s in related field with a minimum of 2 years relevant experience.

15 days ago

Regional Sales Manager, Immunology - San Francisco, CA Galderma Group AG

Boston, MA

$187,000–$198,000 / year

3+ years in Sales Leadership Role; demonstrated successful history of field force management; Ability to lead and manage direct reports, establishing clear expectations, providing coaching, feedback, and assessing and evaluating performance. Engage in one-on-one strategic business meetings with Account Managers and HCPs, help to plan and execute sales meetings, conduct routine performance evaluations of Account Managers, and participate in company sponsored meetings.

30+ days ago

Director, Internships and Work-Based Education Emerson College

Boston, MA

$82,150–$102,650 / year

Working in close partnership with faculty, academic leadership, and industry relations, the Director sets strategy and provides institutional leadership for the infrastructure, policies, systems, and practices that support internships and work-based learning. Reporting to the Assistant Vice President, Career Development, the Director leads the development and implementation of a cohesive, high-quality ecosystem of experiential learning opportunities-both credit-bearing and non-credit-that is aligned with academic priorities, responsive to industry trends, and accessible to all students.

30+ days ago

Director of Nonclinical Safety, Cambridge, MA Isomorphic Labs Limited

Cambridge, MA

At IsoLabs, we are committed to leveraging state-of-the-art AI to advance precision medicine paradigms and establish new benchmarks for both efficacy and safety by consistently delivering the optimal treatments to the appropriate patients at precisely the right time, which we expect to significantly enhance our overall probability of success. By harnessing AI's powerful capabilities, we can use it to model complex biological phenomena to help design novel molecules, anticipate how drug candidates will perform in the clinic and develop medicines to treat and cure some of the world's most devastating diseases.

30+ days ago

General Counsel/Deputy Commissioner Commonwealth of Massachusetts

Boston, MA

Administrator IX'',''Administrator IX'',''United States-Massachusetts-Boston - 1 Federal St'',''United States-Massachusetts-Boston - 1 Federal St'',''Legal Services'',''Legal Services'',''Division of Occupational Licensure'',''Division of Occupational Licensure'',''Full-time'',''Full-time'',''Day'',''Day'',''Aug 21, 2026, 11:34:34 AM'',''Aug 21, 2026, 11:34:34 AM'',''1'',''1'',''188,708.00'',''121,867.30'',''188,708.00'',''Yearly'',''Beth English / Andrew Bridges'',''Beth English / Andrew Bridges'',''6177018600'',''M99-Managers (EXE)'',''M99-Managers (EXE)'',''No'',''No'',''Yes'',''Yes'',''false'',''1091179'',''1091179'',''true'',''1091179'',''false'',''Submission for the position: General Counsel/Deputy Commissioner - (Job Number: 260005SX)'',''false'',''1091179'',''false'',''true''. Under the supervision of the DOL Commissioner, the GCDC manages the day-to-day legal operations of DOL, including the direct supervision of the Deputy General Counsel for Enforcement, the Deputy General Counsel for Boards and Regulations, the Assistant General Counsel for Public Affairs, and the Director of Background Checks.

30+ days ago

Senior Program Manager, Therapeutic Dermatology Galderma Group AG

Boston, MA

$160,000–$200,000 / year

Program Management will work closely with the Program Leader and cross-functional project team members to establish and maintain project plans and budgets, organize and lead project team meetings, foster communication and coordinate between functional groups across clinical, regulatory, quality, MS&T, medical, and commercial areas. This position will be responsible for ensuring adequate resourcing to meet goals, identifying risks/mitigations, and providing project status updates to ensure that the project teams achieve key strategic objectives and ultimately succeed in delivering breakthrough therapies to our patients.

30+ days ago

Director, Global Compliance Zenas BioPharma (USA) LLC

Waltham, MA

$180,000–$226,051 / year

30+ days ago

Regional Sales Manager, Immunology - New York Metro Region, NY Galderma

Boston, Massachusetts

Collaborate to understand the integrity of the use of Galderma Market/Patient Access and Field Reimbursement programs: including but not limited adherence programs and providing education to HCP’s regarding the intent and appropriate use of Galderma’s patient access and reimbursement programs. Engage in one-on-one strategic business meetings with Account Managers and HCPs, help to plan and execute sales meetings, conduct routine performance evaluations of Account Management team, and participate in company sponsored meetings.

12 days ago

Research Aggregate Reports Specialist 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.

23 days ago

Research Aggregate Reports Specialist - Contract TalentBurst, Inc.

Cambridge, MA

$90–$96.77 / hour
Quick Apply

1 day ago

Director, Risk Intelligence And Analytics Biogen Idec

Cambridge, MA

$188,000–$259,000 / year

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. Strong knowledge of end-to-end supply chain principles including experience with external manufacturing ecosystems (e.g., CMOs), regulatory expectations, and industry best practices; Ability to synthesize external signals into actionable internal guidance.

30+ days ago

USA - Engineer Mindlance

Lexington, MA

Quick Apply

The person in this role will be instrumental in working with other members of the Quality Assurance, Quality Control, Supplier Quality, Supply Chain, Manufacturing and Engineering organizations to develop and execute MQ studies and projects to enhance the manufacturing systems and processes to compliantly and efficiently achieve organizational goals. " Supporting the Human Daily Exposure (HDE) program including technical assessments and Extractables/Leachables (E/L) caclulations to ensure patient safety related to commercial Drug Substance (DS) Manufactured at MA Bio Ops.

15 days ago

Product Manager / Senior Product Manager - Catastrophe Models AIR WORLDWIDE CORPORATION

Boston, MA

Full time

Be the voice and face of Verisk catastrophe models to the industry: engage directly with clients throughout the model lifecycle to understand their technical and business requirements, and ensure those needs are reflected from initial design through post-release change management. Unsolicited resumes sent to Verisk, including unsolicited resumes sent to a Verisk business mailing address, fax machine or email address, or directly to Verisk employees, will be considered Verisk property.

6 days ago

Director, Risk Intelligence and Analytics Biogen Inc

Cambridge, MA

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. Strong knowledge of end-to-end supply chain principles including experience with external manufacturing ecosystems (e.g., CMOs), regulatory expectations, and industry best practices; Ability to synthesize external signals into actionable internal guidance.

30+ days ago

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Regulatory Affairs Jobs in Somerville, MA

Medical Programs Specialist Foundation Medical Staffing

Head Of US Field Excellence Biogen Idec

Director, Brand Insights & Competitive Intelligence ITF Therapeutics

Director, Global Compliance Zenas BioPharma

Regional Sales Manager, Immunology - New York Metro Region, NY Galderma Group AG

Pioneer GMP Pipeline (Nationwide) Pioneer GMP Consulting

Material Qualification Engineer LanceSoft Inc

Regional Sales Manager, Immunology - San Francisco, CA Galderma Group AG

Director, Internships and Work-Based Education Emerson College

Director of Nonclinical Safety, Cambridge, MA Isomorphic Labs Limited

General Counsel/Deputy Commissioner Commonwealth of Massachusetts

Senior Program Manager, Therapeutic Dermatology Galderma Group AG

Director, Global Compliance Zenas BioPharma (USA) LLC

Regional Sales Manager, Immunology - New York Metro Region, NY Galderma

Research Aggregate Reports Specialist TalentBurst, Inc.

Research Aggregate Reports Specialist - Contract TalentBurst, Inc.

Director, Risk Intelligence And Analytics Biogen Idec

USA - Engineer Mindlance

Product Manager / Senior Product Manager - Catastrophe Models AIR WORLDWIDE CORPORATION

Director, Risk Intelligence and Analytics Biogen Inc

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