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...

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...

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,...

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...

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...

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...

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...

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...

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...

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...

Senior Consultant - Regulatory Operations Software Implementation (Remote) Join to apply for the Senior Consultant - Regulatory Operations Software Implementation (Remote) role at Veeva Systems Senior Consultant - Regulatory Operations Software Implementation (Remote) Join to apply for the Senior Consultant - Regulatory Operations Software Implementation (Remote) role at Veeva Systems Veeva...

Executive Director, Global Regulatory Operations (Boston, MA) page is loaded## Executive Director, Global Regulatory Operations (Boston, MA)locations: Boston, MAtime type: Full timeposted on: Posted Todayjob requisition id: REQ-26765Job DescriptionGeneral Summary:The Executive Director, Regulatory Operations is responsible for leading the teams of publishing, submission management, regulatory...

The Regulatory Compliance Director is a key part of the Compliance team, collaborating across all areas of the organization with a focus on creating a culture of trust and ethical conduct and promoting detection and prevention of conduct that does not align with DFCI’s ethical standards, federal and state healthcare laws, payer requirements and internal policies. The Regulatory Compliance...

Job Summary The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global regulatory strategies for CMC aspects of small molecule products during late-stage development and throughout the commercial lifecycle. This includes initial marketing application, post-approval changes, and lifecycle management activities...

Senior Director, Regulatory CMC PepGen is at an exciting time in our development. This role is for a motivated and team‑orientated individual who flourishes in an environment where they can help lead and shape our future. As an integrated member of the PepGen Team you will lead, develop, and implement robust regulatory CMC strategies and provide advice on the development and life‑cycle...

Senior Manager, Global Regulatory Affairs Strategy Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our...

Senior Director, Regulatory CMC – Apellis Pharmaceuticals Position Summary The Senior Director, Regulatory CMC will lead and evolve Apellis’s global Chemistry, Manufacturing, and Controls (CMC) strategies to support the company’s innovative therapeutic pipeline and marketed products. This position is responsible for developing, executing, and maintaining high‑impact CMC regulatory strategies...

Regulatory CounselEnvironmental League of Massachusetts### Job DescriptionReporting to: Vice President of Policy and Regulatory Affairs Supporting: ELM and the ELM Action Fund Salary Range: $110,000-$130,000The Environmental League of Massachusetts (ELM) and the ELM Action Fund (ELM AF) are seeking an experienced regulatory attorney to drive our work at the Department of Public Utilities and our...

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...