1,822 Results for

Regulatory Affairs Jobs in Bedford, MA

Jobs

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

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) 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

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

Director, Clinical Pharmacology Seaport Therapeutics

Boston, Massachusetts

Reporting to the VP of Clinical Pharmacology, this role will provide strategic leadership and serve as an independent subject matter expert, shaping dose selection, exposure–response strategy, and overall clinical pharmacology plans, while also contributing hands-on analyses across the portfolio. In the near term, the role will focus on leading clinical pharmacology strategy, study design, modeling & simulation, and CRO oversight for active clinical programs, ensuring regulatory alignment and submission readiness.

14 days ago

Medical Director/Senior Medical Director, Clinical Development Agios Pharmaceuticals

Cambridge, MA

$277,140–$461,900 / year

The current base salary range for this position at the Medical Director is expected to be between $221,600 and $369,333 annualized and the current base salary range for this position at the Senior Medical Director is expected to be between $277,140 and $461,900 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. 3-10 years in industry (biotech/pharma) specifically within Clinical Development or closely related functions Clinical and managerial experience within pharmaceutical trial design and conduct (POC through Phase 3 experience) within the pharmaceutical industry CRO or Academia is required.

30+ days ago

Head of IT - Connected Care Philips

Cambridge, MA

As the BU AI & Data Champion, the role does not build a parallel enterprise AI stack; it consumes and extends the AI & Data Factory and AI COE capabilities, owning the BU-facing demand, use-case value, data products, and community enablement while the enterprise owns the shared platforms and guardrails. The Head of IT for Connected Care is the most senior IT leader embedded in Philips' Connected Care business unit, which encompasses patient monitoring systems, clinical decision support, telehealth platforms, and hospital workflow solutions.

30+ days ago

GxP Project Manager Katalyst HealthCares & Life Sciences Inc

Boston, MA

We are seeking an experienced GxP Project Manager / Consultant to lead and support Quality and Regulatory technology initiatives within the Life Sciences, Biotechnology, or pharmaceutical industry. The ideal candidate will collaborate with Quality, Regulatory, Validation, and IT teams to manage project planning, execution, compliance, and delivery while ensuring alignment with GxP requirements and organizational objectives.

21 days ago

Head Of IT - Connected Care Philips

Cambridge, MA

$279–$446

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

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

Marketing Manager – Knee Robotics 6029-MEDICAL DEVICE BUSINESS SERVICES Legal Entity

Boston, Massachusetts

$102,000–$177,100 / year

Brand Marketing, Brand Positioning Strategy, Business Alignment, Business Storytelling, Business Valuations, Cross-Functional Collaboration, Customer Intelligence, Data Analysis, Data-Driven Decision Making, Digital Strategy, Execution Focus, Financial Analysis, Go-to-Market Strategies, Industry Analysis, Market Research, Negotiation, Problem Solving, Process Improvements, Product Development Lifecycle, Product Improvements, Product Portfolio Management, Product Strategies, Strategic Thinking, Tactical Planning, Technical Credibility The anticipated base pay range for this position is: The Marketing Manager, Knee Robotics will serve as a strategic leader and subject matter expert in Knee Arthroplasty, Robotics and Digital Surgery, supporting and shaping the long-term innovation strategy, technology roadmap, and multigenerational product portfolio for the VELYS Robotic-Assisted Solution.

19 days ago

Associate Director, US Medical Content US Data Management LLC

Lexington, MA

Through partnerships with Microsoft, Google, Oracle, Box, DocuSign, and more, our team helps connect technology, people, and data in ways that generate real outcomes for the organizations that make, regulate, and bring life-saving products to market. USDM Life Sciences is an AI solutions and process automation company built for life sciences - helping pharmaceutical, biotech, and medical device organizations put AI to work across real workflows and scale it safely.

5 days ago

Associate Director, Clinical Pharmacology and Pharmacometrics Dianthus Therapeutics Inc

Cambridge, MA

Our second clinical candidate, DNTH212 is a first and potentially best in class, bifunctional inhibitor that targets clinically validated and complementary disease modifying mechanisms, Type 1 IFN suppression and B cell modulation - enabling potential for improved clinical outcomes and patient friendly convenient, self-administered subcutaneous injections. Support commercialization readiness for late-stage/marketed assets in autoimmune/inflammation and neuromuscular disease/indications including but not limited to generalized myasthenia gravis (gMG), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), and Multifocal Motor Neuropathy (MMN) by quantitatively bridging PK across formulation/device/site changes.

30+ days ago

Associate Director, Analytical Development Dyne Therapeutics Inc

Waltham, MA

$160,000–$200,000 / year

Working closely with CMC, Quality, Regulatory Affairs, Supply Chain, Research and Development, Clinical, and Project Management, this position establishes analytical priorities, resolves complex technical issues, manages program risks, and guides cross-functional decision-making. This role provides strategic and technical leadership for analytical method development, validation, technology transfer, specifications, release testing, stability programs, impurity control, and product characterization.

22 days ago

Post Market Surveillance Specialist, Contract Nova Biomedical Corp

Billerica, MA

Job Summary: The Post Market Surveillance (PMS) Specialist is responsible for preparing Post-Market Surveillance reports, conducting PMS meetings, and supporting the Post Market department in maintaining complaint handling systems, metrics, policies, and procedures to ensure compliance with applicable worldwide regulations and requirements. Nova Biomedical is proud to be a global leader in osmolality testing and biotechnology and in vitro diagnostic (IVD) instrumentation, dedicated to advancing patient care and scientific discovery with a legacy that continues to shape the future of life sciences.

19 days ago

Senior IT Business Analyst, GCP & Data Management Systems Wave Life Sciences Ltd

Lexington, MA

$127,000–$172,000 / year

The role partners closely with Clinical Operations, Clinical Data Management, Biostatistics/Statistical Programming, Pharmacovigilance/Drug Safety, Clinical Quality Assurance, Regulatory Affairs, CROs, and technology vendors to identify business needs, improve processes, develop technology roadmaps, and deliver compliant and scalable solutions supporting clinical development. The position provides leadership across the lifecycle of GCP computerized systems, including platforms supporting eTMF, clinical data, statistical programming, IRT/RTSM, safety, document collaboration, analytics, and system integrations.

5 days ago

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Regulatory Affairs Jobs in Bedford, MA

VP, Medicine Development Leader, Oncology - GI GSK plc

Senior-Project-Engineer Jubilant Pharmova Ltd

Transplant Medical Science Liaison Sanofi

Senior Medical Director, Aatd Sanofi

Sr MSL, Lymphoma (Lacutamab) Swedish Orphan Biovitrum AB

Sr MSL, Lymphoma (Lacutamab) Sobi

Head of Global Labeling CSL Behring LLC

Director, Clinical Pharmacology Seaport Therapeutics

Medical Director/Senior Medical Director, Clinical Development Agios Pharmaceuticals

Head of IT - Connected Care Philips

GxP Project Manager Katalyst HealthCares & Life Sciences Inc

Head Of IT - Connected Care Philips

Director, Global Regulatory Lead - Oncology Takeda Pharmaceutical Co Ltd

Sr. Director, Regulatory Strategy, Infectious Disease Moderna Inc

Marketing Manager – Knee Robotics 6029-MEDICAL DEVICE BUSINESS SERVICES Legal Entity

Associate Director, US Medical Content US Data Management LLC

Associate Director, Clinical Pharmacology and Pharmacometrics Dianthus Therapeutics Inc

Associate Director, Analytical Development Dyne Therapeutics Inc

Post Market Surveillance Specialist, Contract Nova Biomedical Corp

Senior IT Business Analyst, GCP & Data Management Systems Wave Life Sciences Ltd

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