1,836 Results for

Regulatory Affairs Jobs in Massachusetts

Jobs

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

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

Sr MSL, Lymphoma (Lacutamab) Sobi

Waltham, Massachusetts

$215,000–$230,000 / year
Full time

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.

18 days ago

Associate Director, Statistical Programming Alnylam Pharmaceuticals, Inc.

Cambridge, MA

Works closely with Data Management on cross-functional data review and the development and validation of CDISC SDTM specifications and datasets and define packages, may also support Drug Safety to support safety data review and reporting needs, and/or Clinical Pharmacology to support their dataset creation and analytic needs. The Associate Director, Statistical Programming is responsible for statistical programming activities in support of clinical trials including technical and project leadership overseeing the quality and timely delivery of all statistical programming deliverables for studies or for a submission.

30+ 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

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.

11 days ago

Sr. Manager/Assoc Director, Manufacturing Sciences & Technology (MSAT) Genezen

Lexington, MA

$150,000–$170,000 / year
Full time

Collaborate with Process Development, Manufacturing, QC, QA, Engineering, SC, Validation, CMC and Regulatory affairs and ensure that cross functional teams are functioning smoothly to deliver and maintain processes and controls that are timely, phase-appropriately ready for manufacturing to meet clinical and commercial supply needs. . Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.

4 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

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.

14 days ago

Medical Director, Clinical Science – Thoracic Oncologyence 3316 Takeda Development Center Americas

Boston, Massachusetts

$237,200–$372,790 / year

The Medical Director, Clinical Science – Thoracic Oncology provides medical and scientific leadership for the design, execution and interpretation of global clinical studies within Takeda’s thoracic oncology portfolio, spanning non-small cell lung cancer, small cell lung cancer and other intrathoracic malignancies. Reporting to the Executive Medical Director, Oncology Clinical Sciences, the role partners with the Clinical Development lead to translating program strategy into high-quality protocols, robust data and regulatory-grade deliverables that advance assets from first-in-human through registrational studies and lifecycle expansion.

30+ days ago

Principal Scientist (Director), Clinical Research, Immunology Merck & Co Inc

Boston, MA

$255,800–$402,700 / year

Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and assist the Senior Director, Associate Vice-President/Vice-President and Product Development Team Lead in ensuring that appropriate corporate personnel is informed of the progress of studies of our company and competitors' drugs and internal and external expert opinion on scientific questions relevant to his/her areas of responsibility. With a focus on late-stage development, the Clinical Director will manage the entire cycle of clinical development, including determination of appropriate disease indications to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.

30+ days ago

Associate Counsel, Contracting Les Laboratoires Servier SAS

Boston, MA

$189,000–$224,000 / year

Draft, review, negotiate, and finalize a broad range of agreements supporting all business functions, with particular focus on R&D-related agreements, including CDAs, consulting agreements, MSAs, SOWs, clinical trial agreements, sponsored research agreements, research collaborations, material transfer agreements, vendor and CRO agreements, work orders, change orders, sponsorships, grants, data use and transfer arrangements, privacy and data processing agreements, SaaS/IT licenses, amendments, and other business-critical contracts. 4-7+ years of relevant legal experience, including experience in the biopharmaceutical, pharmaceutical, biotechnology, healthcare, or life sciences industry, with demonstrated experience drafting and negotiating a broad range of agreements across business functions and preferred experience with R&D, clinical development, or research-related contracting.

30+ days ago

Senior Director, Alliance Management Halozyme Hypercon Inc

Boston, MA

$214,000–$290,000 / year

The Senior Director, Alliance Management enhances the value and minimizes the risk of strategic partner alliances by providing leadership, proactive management of a portfolio of programs and products, and building strong relationships with key partners and alliance collaborators. This role is accountable for overall alliance performance, driving strategic partnership growth, and integrating efforts across product development, quality, regulatory affairs, manufacturing, project management, and supply chain to achieve critical milestones that advance programs and the Hypercon platform.

30+ days ago

Specialist%2C-Maintenance Jubilant Pharmova Ltd

Burlington, MA

$35.65–$48.23 / hour

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 life changing 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.

29 days ago

Sr Analyst - Financial Planning and Analysis Jubilant Pharmova Ltd

Burlington, MA

$70,500–$112,800 / 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.

24 days ago

Manager%2C-Sales-Operations Jubilant Pharmova Ltd

Burlington, MA

$104,550–$167,280 / 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. This role owns sales operations strategy, Salesforce platform governance, and operational execution to enable sales productivity, data-driven decision making, and customer-centric growth.

28 days ago

Director, Oncology Translational Medicine, Clinical Biomarkers GSK plc

Waltham, MA

$189,750–$316,250 / year

Analytical Thinking, Clinical Data Interpretation, Clinical Data Review, Clinical Development, Clinical Trial Designs, Clinical Trials Monitoring, Digital Fluency, Drug Regulatory Affairs, Executive Presence, Hematology and Oncology, Learning Agility, Matrix Leadership, Real World Evidence (RWE), Scientific Presentations. Supporting disease area strategies and translational objectives by defining biomarker priorities, areas of interest, and generating decision-enabling evidence packages informed by real-world datasets, internal and external data and partnerships (For e.g., research collaborations, KEE consultations).

7 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.

30+ days ago

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Regulatory Affairs Jobs in Massachusetts

Senior Medical Director, Aatd Sanofi

Transplant Medical Science Liaison Sanofi

Sr MSL, Lymphoma (Lacutamab) Sobi

Associate Director, Statistical Programming Alnylam Pharmaceuticals, Inc.

Head of Global Labeling CSL Behring LLC

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

Sr. Manager/Assoc Director, Manufacturing Sciences & Technology (MSAT) Genezen

Director, Global Regulatory Lead - Oncology Takeda Pharmaceutical Co Ltd

Sr. Director, Regulatory Strategy, Infectious Disease Moderna Inc

Associate Director, Clinical Pharmacology and Pharmacometrics Dianthus Therapeutics Inc

Associate Director, Analytical Development Dyne Therapeutics Inc

Medical Director, Clinical Science – Thoracic Oncologyence 3316 Takeda Development Center Americas

Principal Scientist (Director), Clinical Research, Immunology Merck & Co Inc

Associate Counsel, Contracting Les Laboratoires Servier SAS

Senior Director, Alliance Management Halozyme Hypercon Inc

Specialist%2C-Maintenance Jubilant Pharmova Ltd

Sr Analyst - Financial Planning and Analysis Jubilant Pharmova Ltd

Manager%2C-Sales-Operations Jubilant Pharmova Ltd

Director, Oncology Translational Medicine, Clinical Biomarkers GSK plc

Director, Global Trade Waters Corporation

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