1,797 Results for

Regulatory Affairs Jobs in Massachusetts

Jobs

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.

2 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) 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.

15 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

16 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, 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

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 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

Manager/Senior Manager, Biomarker & Biospecimen Operations Candel Therapeutics Inc

Needham, MA

$161,000–$175,000 / year

This role will partner closely with Translational Medicine, Clinical Operations, Data Management, Clinical Development, Regulatory Affairs, Statistics, and external vendors to ensure high-quality, compliant, and inspection-ready biospecimen operations throughout the clinical trial lifecycle. Candel Therapeutics is seeking a Manager/Senior Manager, Biomarker & Biospecimen Operations to oversee biospecimen collection, tracking, shipment, reconciliation, vendor management, and biomarker logistics across clinical development programs.

30+ days ago

Associate Director/Director, Pre-Clinical Program & Alliance Management Kiniksa Pharmaceuticals

Lexington, Massachusetts

$191,000–$242,000 / year

This individual will serve as the central operational hub for one or more pre-clinical assets, coordinating cross-functional activities across research, CMC, nonclinical safety/toxicology, translational, regulatory, and program leadership, while also managing day-to-day interactions with external partners, CROs, and collaborators. Kiniksa is seeking a highly organized and execution-oriented Associate Director / Director, Pre-Clinical Program and Alliance Management to drive the operational planning, integration, and delivery of pre-clinical programs from candidate nomination through successful IND filing and acceptance.

26 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.

12 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

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

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

Associate Director, Specialty Pharmacy Operations Madrigal Pharmaceuticals

Waltham, Pennsylvania

Remote

$180,000–$221,000 / year

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process.

30+ days ago

Director, Evidence Generation Kiniksa Pharmaceuticals

Lexington, Massachusetts

$191,000–$264,000 / year

In close collaboration with Global Medical Affairs and cross-functional team members, this role will be responsible for driving the execution of a variety of evidence generation activities such as studies on natural history of disease, treatment trends, claims data, qualitative/quantitative research, and registries. With deep expertise in immunology and inflammation, Kiniksa is advancing a growing portfolio of approved and investigational medicines, anchored by its lead product, ARCALYST®, the first and only FDA‑approved therapy for recurrent pericarditis.

26 days ago

Clinical Development Medical Director, Hematology Pfizer

Cambridge, MA

$239,900–$399,800 / year

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act.

30+ days ago

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Regulatory Affairs Jobs in Massachusetts

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

Transplant Medical Science Liaison Sanofi

Sr MSL, Lymphoma (Lacutamab) Swedish Orphan Biovitrum AB

Senior Medical Director, Aatd Sanofi

Sr MSL, Lymphoma (Lacutamab) Sobi

Head of Global Labeling CSL Behring LLC

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

Manager/Senior Manager, Biomarker & Biospecimen Operations Candel Therapeutics Inc

Associate Director/Director, Pre-Clinical Program & Alliance Management Kiniksa Pharmaceuticals

Associate Director, Clinical Pharmacology and Pharmacometrics Dianthus Therapeutics Inc

Associate Director, Analytical Development Dyne Therapeutics Inc

Associate Counsel, Contracting Les Laboratoires Servier SAS

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

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

Senior Director, Alliance Management Halozyme Hypercon Inc

Associate Director, Specialty Pharmacy Operations Madrigal Pharmaceuticals

Director, Evidence Generation Kiniksa Pharmaceuticals

Clinical Development Medical Director, Hematology Pfizer

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