regulatory officer jobs in Cambridge, MA

A state agency of Massachusetts is seeking an attorney to serve as a Hearing Officer with responsibilities in overseeing electric power, natural gas, and water industries. The role involves managing legal process, preparing legal documentation, and participating in settlements. Applicants must have a JD, Bar admission, and preferably experience in relevant law. The position allows for...

Summary: Reporting to the Chief Medical Officer and collaborating with external regulatory advisors, this role is responsible for developing and executing regulatory strategies from early development through late-stage clinical programs. The role involves direct interaction with the FDA and global regulatory agencies, leading submissions, and providing regulatory guidance across functional...

Associate Director, Global Regulatory Affairs Cambridge, US; New Jersey, US | full time | Job ID:9842 Company Summary BioNTech is a Nasdaq listed Germany-based global biotechnology commercial stage company with U.S. offices in Cambridge, MA and Gaithersburg, MD, that focuses on developing cancer therapeutics, including individualized immunotherapy, as well as vaccines for infectious diseases,...

COMPANY MISSION eGenesis is dedicated to giving patients with organ failure a second chance at life by harnessing the power of genome engineering to create safe, effective, and readily available solutions. POSITION SUMMARY Reporting to the Senior Vice President of Development and based in our Cambridge, MA office, the Associate Director of Regulatory Affairs is responsible for developing and...

POSITION SUMMARY Position Title: Vice President, Regulatory Affairs Reports to: CMO Company Summary: Client is a stem cell therapeutic company developing an innovative platform technology for generating self-renewing blood stem cells. We have breakthrough potential to provide patients with rapid and broad access to HLA-compatible transgene‑free blood stem cell therapies. Client is committed...

Senior Director/Vice President, Regulatory AffairsJoin to apply for the Senior Director/Vice President, Regulatory Affairs role at Korro Bio, Inc.Company SummaryKorro is a biopharmaceutical company focused on developing a new class of genetic medicines for both rare and highly prevalent diseases using its proprietary RNA editing platform. Korro is generating a portfolio of differentiated programs...

Job TitlePrincipal Regulatory Affairs SpecialistJob DescriptionThe Principal Regulatory Affairs Specialist will develop and execute the regulatory strategy for new product development, design changes, and field safety corrections, with a primary focus on Software as a Medical Device (SaMD) for our Sleep & Respiratory Care products in the U.S., EU, and Rest of World products.Your role:Author 510K...

Principal Regulatory Affairs Specialist page is loaded## Principal Regulatory Affairs Specialistlocations: Murrysville: Cambridge (US): New Kensingtontime type: Full timeposted on: Posted 8 Days Agojob requisition id: 564979### Job TitlePrincipal Regulatory Affairs Specialist### Job DescriptionThe Principal Regulatory Affairs Specialist will develop and execute the regulatory strategy for new...

Director, Regulatory Affairs (U.S. Advertising and Promotion)The Director, Regulatory Affairs for U.S. Advertising and Promotion (USAP) will provide strategic regulatory advice to internal stakeholders regarding tactics and communications related to Alnylam's marketed products, investigational treatments, and disease areas to healthcare providers, patients, payers, and other audiences. A critical...

Cambridge, US; New Jersey, US | full time | Job ID: 9842 Position Summary The Associate Director, Regulatory Affairs (Advertising and Promotion) will have accountability for review and approval of US promotional materials and medical communications of assigned brand(s). This colleague will provide input and execute regulatory compliance/strategy related to promotional and advertising campaigns...

OverviewModerna Therapeutics is seeking an Associate Director of Regulatory Strategy to support programs within the oncology franchise in one of Moderna’s US offices. This role is for a forward‑looking, creative and agile regulatory strategist able to anticipate and address challenges involved in developing and registering oncology therapeutics/vaccines based on messenger RNA technology in the US...

AVP, Regulatory Relations Senior Associate - TreasuryCountry: United States of America Your Journey Starts Here: Santander is a global leader and innovator in the financial services industry. We believe that our employees are our greatest asset. Our focus is on fostering an enriching journey that empowers you to explore diverse career opportunities while nurturing your personal growth. We are...

Director, Regulatory Advertising and Promotion N.A. Position overview: The Director Regulatory Advertising and Promotion N.A is responsible for providing strategic and tactical regulatory ad promo support and guidance related to product and disease state communications for assigned product(s) or therapeutic area across the product life cycle. As the internal subject matter expert on FDA...

Principal Medical Writer - Regulatory and Medical Writing Join to apply for the Principal Medical Writer - Regulatory and Medical Writing role at Ionis Pharmaceuticals, Inc. Principal Medical Writer - Regulatory and Medical Writing Join to apply for the Principal Medical Writer - Regulatory and Medical Writing role at Ionis Pharmaceuticals, Inc. Get AI-powered advice on this job and more...

Associate Director, Regulatory Affairs, Advertising and Promotion Join to apply for the Associate Director, Regulatory Affairs, Advertising and Promotion role at Madrigal Pharmaceuticals Associate Director, Regulatory Affairs, Advertising and Promotion 6 days ago Be among the first 25 applicants Join to apply for the Associate Director, Regulatory Affairs, Advertising and Promotion role at...

Overview Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs at Olema Oncology. Reports to the Senior Vice President of Regulatory Affairs. Location: Boston, MA or San Francisco, CA. Domestic and international travel up to 20%. Responsibilities - Lead the development of the New Drug Application (NDA) - Lead the development and execution of innovative regulatory strategies...

About Us Catalyst Labs is a leading talent agency with a specialized vertical in Legal, Regulatory Compliance, and Corporate Governance. We operate deeply inside our clients’ hiring processes not as an external vendor, but as an embedded extension of their executive and in-house legal teams. We collaborate directly with General Counsels, Chief Compliance Officers, Partners, and Heads of Legal...

Associate Director, Regulatory Affairs, Advertising and Promotion page is loaded Associate Director, Regulatory Affairs, Advertising and PromotionlocationsMA - Waltham - Office time typeFull time posted onPosted Today job requisition idJR_000080 ABOUT MADRIGAL: Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic...

A global health technology company is seeking a Principal Regulatory Affairs Specialist to develop regulatory strategies for new product development, focusing on Software as a Medical Device. The ideal candidate has over 7 years of experience in Regulatory Affairs and expertise in FDA and EU regulations. This role is essential in guiding cross-functional teams and communicating regulatory...

Overview Santander is a global leader and innovator in the financial services industry. We believe that our employees are our greatest asset. Our focus is on fostering an enriching journey that empowers you to explore diverse career opportunities while nurturing your personal growth. We are committed to creating an environment where continuous learning and development are prioritized, enabling...