1,818 Results for

Regulatory Affairs Jobs in Bedford, MA

Jobs

Head of Commercial, US Oncology Les Laboratoires Servier SAS

Boston, MA

$350,000–$450,000 / year

The VP will partner closely with Market Access, Business Excellence, Medical and Patient Affairs, Regulatory Affairs, Manufacturing, Finance, Legal and Compliance, Corporate Affairs and Global Commercial teams to ensure seamless execution of commercial strategy across the product lifecycle. The role will lead over a 100 marketing and sales professionals aligned to the oncology portfolio and will have general management responsibilities including oversight of all brand management, launch activities, and will hold full accountability for the delivery of the P&L of the oncology business.

30+ days ago

Director, Clinical Program Quality and Excellence Takeda Pharmaceutical Co Ltd

Boston, MA

$177,000–$278,080 / year

You will partner closely with global cross-functional stakeholders, including Clinical Development, Study Execution Teams, Regulatory Affairs, and Quality organizations, to identify emerging risks, drive issue resolution, and strengthen quality performance across clinical programs. This role is responsible for shaping and executing risk-based quality management strategies across assigned clinical programs, ensuring inspection readiness, regulatory compliance, and proactive quality oversight throughout the clinical trial lifecycle.

30+ days ago

Drug Product Process Scientist - Small Molecule Takeda Pharmaceutical Co Ltd

Boston, MA

$154,400–$242,550 / year

Expert-level knowledge of drug product process development, commercial manufacturing, process characterization, validation, continued process verification, technology transfer, scale-up, quality risk management, GMP compliance, Regulatory CMC submissions, and lifecycle management. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

26 days ago

Drug Product Process Scientist - Small Molecules Takeda

Boston, Massachusetts

$137,000–$215,270 / year

23 days ago

Senior Counsel Operations and Pharmacy Legal AbbVie Inc

Waltham, MA

Responsibilities: Serve as a key legal advisor to cross-functional business teams, providing proactive counsel on commercial, regulatory, or operational issues Interpret and apply U.S. laws and global regulations relevant to the pharmaceutical or healthcare environment Review and advise on contracts, business activities, and strategic initiatives to ensure legal compliance and alignment with company objectives. The role will support various Operations stakeholders, including AbbVie's onsite Pharmacy and advise on pharmacy regulatory compliance, controlled substance management, pharmacy licensure matters, as well as commercial contracts requests.

30+ days ago

Director Of Financial Aid Benjamin Franklin Cummings Institute of Technology

Boston, MA

$85,000–$105,000 / year

The Director also provides strategic oversight of the College's outsourced financial aid partner (FA Solutions), establishing performance expectations, monitoring service delivery, ensuring contractual compliance, and fostering a collaborative partnership that supports institutional goals and an exceptional student experience. As a key member of the Enrollment Services leadership team, the Director collaborates closely with Admissions, Student Accounts, the Registrar, Student Affairs, Finance, Information Technology, Academic Affairs, and external agencies to remove financial barriers and advance the College's enrollment and student success goals.

30+ days ago

Director, Global Marketing GI Oncology (New Product Planning) Takeda

Boston, Massachusetts

$177,000–$278,080 / year

About the role: As part of the Global Oncology Products & Pipeline Strategy (GOPPS) global marketing team, the Director, Global Marketing GI Oncology (New Product Planning), reports to the Head of GI Oncology and works in the gastric cancer and/or pancreatic ductal adenocarcinoma (PDAC) spaces. R&D, Medical Affairs, Market Access, Market Research, Forecasting, Analytics, Competitive Intelligence, Patient Advocacy, New Product Planning, OBU countries) to develop opportunity assessments based on robust insights to inform Target Product Profile (TPP), R&D prioritization, positioning and business case.

14 days ago

Cluster Lead, Pharmacovigilance, LATAM ModernaTX

Cambridge, Massachusetts

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Provide dynamic leadership and strategic oversight of PV operations in Latin America, ensuring excellence in execution, and define the PV strategy for the region and develop actionable short-, medium-, and long-term plans to achieve safety and compliance goals.

6 days ago

Associate Director, Bioanalytical Development Formation Bio

Boston, MA; New York

$177,500–$232,000 / year

The Associate Director, Bioanalytical will lead bioanalytical strategy and delivery for assigned programs, working across nonclinical and clinical teams to ensure assays are fit for purpose and support key development decisions. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials.

16 days ago

Corporate Counsel HP Hood

Boston, MA

$165,000–$185,000 / year

This position also will draft, review, and negotiate a broad range of commercial agreements for numerous business teams, including Sales, Procurement, Marketing, Regulatory Affairs, Information Technology, Operations, and other areas of the company. Review consumer-facing materials across traditional, digital, social media, influencer, and e-commerce channels; assess legal risk; and provide practical guidance to business stakeholders.

14 days ago

Senior Director, Human Resources Harvard University

Cambridge, MA

Reporting to the Managing Director of Human Resources Consulting, the Senior Director of Human Resources partners with leaders across Harvard Human Resources, Harvard Public Affairs & Communications, and Alumni Affairs & Development, and potentially another client within Central Administration. The role leads a Human Resources team supporting approximately 700-1000 Central Administration employees and manages a team that delivers day-to-day Human Resources services to these business units.

9 days ago

VP, Medicine Development Leader, Oncology - GI GSK plc

Waltham, MA

$266,250–$443,750 / year

Business Strategies, Collaborative Partnerships, Commercial Acumen, Digital Fluency, Drug Development, Drug Regulatory Affairs, Evidence Based Decision Making, Executive Presence, Hematology and Oncology, Innovative Leadership, Matrix Leadership, Prioritization, Scientific Data Analysis, Scientific Presentations, Team Development. Partners with the Pipeline Project Manager (PPM), energizes and motivates the MDT to drive a high performing team and operational delivery of the project, including setting team objectives to ensure successful project delivery, including options for acceleration, parallel indication development and smart risk-taking.

5 days ago

Senior-Project-Engineer Jubilant Pharmova Ltd

Burlington, MA

$103,050–$164,900 / year

As Spokane's Largest Manufacturing Company, Jubilant HollisterStier LLC is a well-established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support lifechanging medicines around the world. We are nationally recognized for our expertise in producing sterile injectable vials and lyophilized products, and our Allergy business is a global leader in allergenic extracts that support treatments for allergies and asthma.

30+ days ago

Sr MSL, Lymphoma (Lacutamab) Swedish Orphan Biovitrum AB

Waltham, MA

$215,000–$230,000 / year

Identify, document, and share high-quality field insights on unmet needs, clinical practice, patient pathways, evidence gaps, stakeholder perspectives, competitive developments, and the treatment landscape. Partner with colleagues in Medical Affairs, Medical Information, Clinical Development, Market Access, Patient Advocacy, Commercial, Legal, Compliance, and other functions, while maintaining the independence and integrity of the Medical Affairs role.

25 days ago

Transplant Medical Science Liaison Sanofi

Cambridge, MA

Remote

$146.25–$211.25 / hour

The responsibility of the Transplant MSL is to establish scientific and professional credibility with customers and other healthcare stakeholders, communicate appropriately and compliantly via scientific exchange on the value of Sanofi products, provide insights to internal teams on key medical education gaps relevant to healthcare decision makers, healthcare providers and identify clinical research sites or educational opportunities when appropriate. The Transplant MSL shares scientific and clinical data exceptionally well, communicating directly with US healthcare providers and clinical researchers via appropriate compliant scientific exchange, clinical research, disease state awareness/education and medical education gaps.

30+ days ago

Senior Medical Director, Aatd Sanofi

Cambridge, MA

$236,250–$341,250 / year

Optimize the structure and format of AATD medical content and publications to enhance discoverability and effective processing by large language model (LLM) systems, ensuring Sanofi's scientific communications are accessible and accurately represented in AI-driven information environments. The successful candidate will create a US medical plan, provide authoritative scientific leadership across the AATD landscape, mentor and develop field-based medical talent, and collaborate with cross-functional teams to advance Sanofi's AATD portfolio from late-stage development through commercialization.

30+ days ago

Sr MSL, Lymphoma (Lacutamab) Sobi

Waltham, Massachusetts

$215,000–$230,000 / year
Full time

26 days ago

Head of Global Labeling CSL Behring LLC

Waltham, MA

You'll set global labelling strategy, balancing business need against the core obligation of getting benefit/risk information right for the people relying on it, and you'll ensure the underlying processes deliver accurate, timely labelling information that supports the safe and effective use of Seqirus' products, importantly, including the regulatory requirements around timely safety-related updates. You'll work closely with cross-functional stakeholders including Global Safety, Clinical Development, Commercial and Supply Chain to ensure effective and timely labelling deliverables meet business needs across every region Seqirus operates in.

30+ days ago

Sr. Director, Regulatory Strategy, Infectious Disease Moderna Inc

Cambridge, MA

$196,700–$353,400 / year

Director will be a strategic leader within Global Regulatory Science, responsible for developing and executing regulatory plans for assigned programs, and as an expert within Regulatory, will be relied on to articulate clear and compelling regulatory strategy, highlighting risks and opportunities when appropriate, accounting for the complex interplay between major global Health Agencies, and leveraging the mRNA platform technology. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

30+ days ago

Director, Global Regulatory Lead - Oncology Takeda Pharmaceutical Co Ltd

Boston, MA

$177,000–$278,080 / year

Strong and independent skills in 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. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

30+ days ago

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Regulatory Affairs Jobs in Bedford, MA

Head of Commercial, US Oncology Les Laboratoires Servier SAS

Director, Clinical Program Quality and Excellence Takeda Pharmaceutical Co Ltd

Drug Product Process Scientist - Small Molecule Takeda Pharmaceutical Co Ltd

Drug Product Process Scientist - Small Molecules Takeda

Senior Counsel Operations and Pharmacy Legal AbbVie Inc

Director Of Financial Aid Benjamin Franklin Cummings Institute of Technology

Director, Global Marketing GI Oncology (New Product Planning) Takeda

Cluster Lead, Pharmacovigilance, LATAM ModernaTX

Associate Director, Bioanalytical Development Formation Bio

Corporate Counsel HP Hood

Senior Director, Human Resources Harvard University

VP, Medicine Development Leader, Oncology - GI GSK plc

Senior-Project-Engineer Jubilant Pharmova Ltd

Sr MSL, Lymphoma (Lacutamab) Swedish Orphan Biovitrum AB

Transplant Medical Science Liaison Sanofi

Senior Medical Director, Aatd Sanofi

Sr MSL, Lymphoma (Lacutamab) Sobi

Head of Global Labeling CSL Behring LLC

Sr. Director, Regulatory Strategy, Infectious Disease Moderna Inc

Director, Global Regulatory Lead - Oncology Takeda Pharmaceutical Co Ltd

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