- Merck & Co. (Boston, MA)
- …(including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations).Provide ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- ThermoFisher Scientific (Waltham, MA)
- …opportunities to make significant contributions to the world. **Discover Impactful Work:** The Director of Regulatory Affairs (RA) is responsible for owning ... The RA Director is able to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …stem cell transplant. In this position you will build and lead a cell medicine regulatory affairs team and provide regulatory leadership and oversight to the ... development of innovative regulatory affairs and CMC regulatory ...and internal stakeholders. A typical day as an Executive Director might look like: + Responsible for the strategic… more
- Takeda Pharmaceuticals (Boston, MA)
- …global vaccine programs in various stages of development + Represents the vaccine regulatory affairs team on cross-functional Takeda Vaccines teams to ensure ... CMC regulations and guidelines by applying interpersonal skills and expert regulatory CMC knowledge to identify, communicate, address, and overcome challenges that… more
- Sanofi Group (Cambridge, MA)
- …Your skills could be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs (GRA)-Advertising and Promotion (A-P) ... digital transversal initiatives and associated cross-functional teams + Lead GRA A-P regulatory deliverables in support of technology evolution, and Gen AI supported… more
- Novo Nordisk (Lexington, MA)
- …across multiple functional areas. Relationships You will report to the Senior Director , Regulatory Affairs (based in Lexington). Essential Functions ... difference? The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational medicines. You… more
- AbbVie (Waltham, MA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead, Global ... approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic… more
- CVS Health (Boston, MA)
- …Services division and broader PBM business. This position reports directly to the Director of Medicare Regulatory Affairs . **Duties and Responsibilities:** ... we do it all with heart, each and every day. This Senior Manager, Regulatory Affairs position is a crucial contributor to the Medicare regulatory and… more
- Merck (Boston, MA)
- **Job Description** The Executive Director (ED) for Field Medical Affairs in the US understands our Company's corporate and products/portfolio strategies and ... work cross-functionally with the Global Medical and Scientific Affairs Therapeutic Area teams to align on Global medical...in a highly matrixed environment is critical. The Executive Director provides strategic and tactical direction to the field… more
- Sumitomo Pharma (Boston, MA)
- …Strateg** **y (** **Hematology/Oncology** **)** will be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs ... and Commercial launch strategy and guide the tactical implementation of Medical Affairs plans. The Associate Director will also collaborate with company… more
- Sumitomo Pharma (Boston, MA)
- …, Medical Strategy (Prostate Cancer)** will be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy. ... initiatives and advance patient advocacy efforts to ensure that Medical Affairs activities align with patient focused programs. **Job Duties and Responsibilities**… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Global Medical Affairs Senior Director Kevzara **Grade:** L4-2 **Location** : Cambridge, MA **About the Job** In order to pursue Sanofi's purpose ... engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs to develop and launch first in class and best… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Medical Affairs Director - Evidence Generation, Respiratory **Location:** Cambridge, MA Our Medical function serves as a valued strategic partner ... with Clinical, Commercial, Regulatory , and Market Access on therapeutic solutions to support...years' experience in industry preferably in R&D or Medical Affairs . + Prior experience in Clinical trials, including understanding… more
- Takeda Pharmaceuticals (Lexington, MA)
- …of proposed promotional and disease state materials. + Collaborate with Regulatory Affairs , Medical, Legal, Commercial, and Compliance, execute and ... to the best of my knowledge. **Job Description** **Associate Director , US Advertising & Promotion Regulatory Review**... regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the… more
- Takeda Pharmaceuticals (Boston, MA)
- … Project Management and Strategic Planning - Neuroscience TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the Global ... changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global Regulatory Project Management… more
- Takeda Pharmaceuticals (Boston, MA)
- …area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively ... area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- Sanofi Group (Cambridge, MA)
- …Ready to get started? **Main Responsibilities** + In conjunction with the Global Regulatory Affairs Head of Global Advertising & Promotion, recommend and ... **Job Title** : Senior Director , Global Regulatory Advertising and Promotion...assigned. **About You** **Experience** + Successful track record in Regulatory Affairs with 7 -10+ years of… more
- Takeda Pharmaceuticals (Boston, MA)
- …area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively ... area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- Takeda Pharmaceuticals (Boston, MA)
- …primary liaison to the US FDA and provides support for regional and local regulatory affairs teams for interactions with international regulatory Agencies ... interactions/meetings related to assigned programs and supports regional and local regulatory affairs teams with health authority interactions. + Ensures… more
- State of Massachusetts (Boston, MA)
- …intended to streamline the permitting and approval process for development projects. The Director of the Permit Regulatory Office will be the point of ... state agencies that issue project permits and approvals. This position will serve as director of the permit regulatory office established within EOED by section… more
