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...

Job Description Job Description About Immuneering: Immuneering is a clinical-stage oncology company outpacing cancer to help patients outlive their disease. Our lead product candidate, atebimetinib (IMM-1-104) is currently in a Phase 2a trial in patients with advanced solid tumors including pancreatic cancer. Immuneering’s R&D team is based in a ~38,000 square foot lab and office facility in...

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...

Job Description Job Description Company Summary: Korro 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 that are designed to harness the body’s natural RNA editing process to effect a precise yet transient single...

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...

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...

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...

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...

Company Summary: Korro 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 that are designed to harness the body’s natural RNA editing process to effect a precise yet transient single base edit. By editing RNA instead...

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...

Regulatory Reporting Senior Associate, Controllership - RemoteCountry: United States of America It Starts Here: Santander is a global leader and innovator in the financial services industry and is evolving from a high-impact brand into a technology-driven organization. Our people are at the heart of this journey and together, we are driving a customer-centric transformation that values bold...

Job Description Job Description Associate Director, Regulatory CMC – Solid Biosciences Charlestown, MA HQ Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, including Duchenne muscular dystrophy (Duchenne), Friedreich’s ataxia (FA), catecholaminergic polymorphic ventricular...

Head of Quality & Regulatory Compliance (QRC) at AG Mednet Description Overview AG Mednet is a software platform company operating at the intersection of clinical trials, data integrity, and regulatory compliance, supporting life sciences customers worldwide. We are seeking a Head of Quality & Regulatory Compliance (QRC) to provide strategic leadership and oversight of our quality and...

General Summary: The Executive Director, Regulatory Operations is responsible for leading the teams of publishing, submission management, regulatory information management, compliance and the regulatory management office. This role will be accountable for creating a high quality organization that utilizes the best in technology, process and project management to deliver global submissions in a...

Job Description Job Description Director, Regulatory Strategy – Solid Biosciences Charlestown, MA HQ Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, including Duchenne muscular dystrophy (Duchenne), Friedreich’s ataxia (FA), catecholaminergic polymorphic ventricular...

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...

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...