- Merck & Co. (Boston, MA)
- …scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations) for ... physician-scientist to join our group as a- Principal Scientist (Clinical Director ) in Translational Medicine/Early Clinical Development in the Cardiovascular and… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on ... Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include… more
- AbbVie (Waltham, MA)
- …LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy , is responsible for developing and ... and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. As an Associate Director , Global Regulatory Affairs Marketed Products you will define, ... regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- Merck (Boston, MA)
- **Job Description** The Regulatory Affairs Headquarters Principal Scientist is responsible for development and implementation of global regulatory ... point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and...(GRACS) and external to GRACS. + Develops worldwide product regulatory strategy to optimize label and obtain… more
- Takeda Pharmaceuticals (Boston, MA)
- …knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking an Associate Director , Global Regulatory Affairs in Cambridge, MA with the ... following requirements: Master's degree in Pharmacy, Biomedical Engineering, Regulatory affairs or related field plus 7 years of related experience. Prior… more
- Takeda Pharmaceuticals (Lexington, MA)
- …executes and manages regulatory submissions per the GRA CMC Product Team technical regulatory strategy + Guide the team to define and drive strategy ... in a GRA CMC Product Team lead role, prepares and maintains relevant regulatory documentation (eg, technical regulatory strategy documents, storyboards, risk… more
- AbbVie (Cambridge, MA)
- …Development and Pipeline cross-functional teams and drives the development of medical affairs objectives aligned with strategy . + Reviews, assesses and reports ... and scientific strategic and operational input into core medical affairs activities such as: healthcare professional/provider interactions (HCPs, Patients and… more
- AbbVie (Waltham, MA)
- …Will consider remote candidates. Purpose: The Associate Medical Director /Associate Scientific Director provides specialist medical/scientific strategic ... and operational input into core medical affairs activities within their TA inclusive of healthcare professional/provider interactions; generation of clinical and… more
- AbbVie (Cambridge, MA)
- …statistics, regulatory , etc.) as they relate to on-going medical affairs projects. + Experience in Neuroscience/Psychiatry preferred. + May assist as consultant ... be determined by the qualifications listed below. Purpose The Associate Scientific Director provides medical and scientific strategic and operational input into core… 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)
- … regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively ... therapies to patients worldwide. Join Takeda as a Senior Director , Global Regulatory Lead, GI & Inflammation... strategy such as understanding broad concepts within regulatory affairs and implications across the organization… more
- Takeda Pharmaceuticals (Boston, MA)
- …Regulatory Project Management and Strategic Planning - GI2 TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the Global ... goals and regulatory submissions in accordance with regulatory strategy for moderately complex programs and...through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global … more
- Merck (Boston, MA)
- …+ Stay updated on emerging regulations and industry trends affecting device quality and regulatory affairs . Strategic Contributions + Serve as a key member of ... the strategic direction of the company's product pipeline and regulatory strategy . + Drive operational excellence initiatives...+ 10+ years of experience in device quality, device regulatory affairs , or a related field within… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …Senior Management Cross-Functional Team (GLOC)** + In alignment with Head, Global Regulatory Affairs Marketed Products and Labeling, coordinates the process to ... plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases. The Director , Global Labeling Strategy Lead is a key role in the… more
- Takeda Pharmaceuticals (Boston, MA)
- …FDA/EMA/PMDA regulations; ICH guidance; GLP/GCP requirements; SEND requirements, etc.). + Regulatory Affairs Credential (RAC-Drugs) is an advantage. + Strong ... the best of my knowledge. **Job Description** **About the role:** **Associate Director , Nonclinical Regulatory Writing and Submission Support,** **_Oncology and… more
- Takeda Pharmaceuticals (Boston, MA)
- …of company Subject Matter Experts across Global R&D (Pharmaceutical Sciences, CMC Regulatory Affairs & Devices), Global Manufacturing Supply and Global ... true to the best of my knowledge. **Job Description** Senior Technical Regulatory Advisor - Pharmaceuticals (Senior/Executive Director ) OBJECTIVES/PURPOSE + To… more
- Actalent (Boston, MA)
- …or PhD preferred. + Minimum of 5+ years of relevant experience in CMC Regulatory Affairs for biologics, including IND activity, global CTAs, DSURs and Agency ... to Boston area to accommodate flexible hybrid schedule Responsibilities: + Actively represent Regulatory CMC and provide regulatory expertise as a member of… more
- Takeda Pharmaceuticals (Boston, MA)
- …all applicable laws, regulations, and policies + Interact directly with Clinical, Statistics, Regulatory Affairs , and Medical Affairs to fully understand ... publications best practices and the development of scientific communications strategy and deliverables, the **Associate Director , Scientific Communications… more
- Sanofi Group (Cambridge, MA)
- …+ Collaborate with glocal cross-functional teams including Medical TA, Clinical Development, Regulatory Affairs , HEVA, Market Access, and Commercial to align ... **Job Title:** Medical Director - Global Medical Evidence Generation **Location:** Cambridge, MA **About the Job** We are an innovative global healthcare company,… more
