- Fresenius Medical Center (Waltham, MA)
- …AND SCOPE:** Assists in the support of the daily operational activities within Regulatory Affairs for the preparation of regulatory submissions required ... RESPONSIBILITIES:** + A seasoned, experienced professional with a full understanding of Regulatory Affairs ; resolves a wide range of issues in creative ways. +… more
- Takeda Pharmaceuticals (Boston, MA)
- …and clinical aspects of drug development and associated regulations. + May serve as global regulatory lead (GRL) on the global project team (GPT) ... + Collaborates with all Takeda regions to ensure a global regulatory strategy is created and executed...regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization… more
- Sanofi Group (Cambridge, MA)
- …In at least one product area, you will be considered the resident expert in Global Regulatory Affairs Region NA, Advertising & Promotion (A&P) group on ... **Job title** : Director, US Regulatory Affairs - Advertising and Promotion...with the Sr . Director/Product Support Head, imparts senior regulatory guidance and advice during issues… more
- Sanofi Group (Cambridge, MA)
- …thought was possible. Ready to get started? **Main Responsibilities** + In conjunction with the Global Regulatory Affairs Head of Global Advertising & ... **Job Title** : Senior Director, Global Regulatory ...assigned. **About You** **Experience** + Successful track record in Regulatory Affairs with 7 -10+ years of… more
- Takeda Pharmaceuticals (Boston, MA)
- …to pharmaceutical drug and device. + Serve as the expert for device labeling on the global Regulatory Affairs (RA) Sub team and Global Device Sub ... hematologic, and other complex diseases. The Global Regulatory Device Labeling Strategy Lead ( Senior Manager)...experience in the biopharmaceutical industry (eg, safety, ad promo, regulatory strategy, medical affairs , etc.). Up to… more
- Takeda Pharmaceuticals (Boston, MA)
- …working groups to liaise effectively with cross-functional team members (Program Management, Global Regulatory Affairs , Regulatory Operations, Drug ... on cross-functional teams (Clinical, Global Patient Safety, Program Management, Global Regulatory Affairs , Regulatory Operations) to plan, generate,… more
- Teleflex (Chelmsford, MA)
- Sr . Regulatory Affairs Specialist **Date:** Mar 11, 2025 **Location:** Chelmsford, MA, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ... ID** :11911 **About Teleflex Incorporated** As a global provider of medical technologies, Teleflex is driven by...make a difference in patients' lives. **Position Summary** The Sr . Regulatory Affairs Specialist (SRA)… more
- Olympus Corporation of the Americas (Westborough, MA)
- …in selected global markets. The individual acts as an SME in international regulatory affairs and will provide international regulatory expertise in new ... Duties** + Participate in the preparation and maintenance of global registration dossiers for global market approval....and/or other relative experience. + Minimum 5 years prior regulatory affairs experience in the medical device… 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 ... engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs ...that address highest unmet needs. We are an innovative global healthcare company, committed to transforming the lives of… more
- Cardinal Health (Boston, MA)
- …part of the broader Personal Protective Equipment (PPE) portfolio. **_Job Summary_** The Senior Global Product Specialist will lead core product marketing and ... objectives that enable sustainable growth. This candidate will report to the Senior Global Product Manager of ICA and Facial Protection. **_Responsibilities_**… more
- Sanofi Group (Cambridge, MA)
- …the organization **Cross-functional Collaboration:** + Work closely with clinical development, regulatory affairs , market access, and commercial teams to align ... **Job Title:** Head of Global Medical Affairs , Solid Tumors **Location**...the pharmaceutical industry, with at least 5 years in senior medical affairs roles + Extensive knowledge… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Leads and expands Neuroscience Therapeutic Area (TA) including hiring of Global Medical Affairs (GMA) professionals covering different therapeutic indications ... and execution of GMA multi-year strategic plan.** **Serves as member of the Global Portfolio Division Senior Leadership Team.** **Accountable for development and… more
- Merck (Boston, MA)
- … Global Clinical Development, and IIS teams + Assists Country Medical Affairs senior leadership with field medical strategic planning and resource management ... our Company's corporate and products/portfolio strategies and work cross-functionally with the Global Medical and Scientific Affairs Therapeutic Area teams to… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** **_Objective / Purpose:_** + Defines, develops and leads global strategies to maximize global regulatory success towards ... + Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of … more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Senior Manager, Global Regulatory Labeling Strategy where you will ... Coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team ( Global Labeling Oversight...issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk… more
- Merck (Boston, MA)
- …scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations) ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- Novo Nordisk (Lexington, MA)
- …decision-makers across multiple functional areas. Relationships You will report to the Senior Director, Regulatory Affairs (based in Lexington). Essential ... difference? The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational medicines.… more
- Sanofi Group (Cambridge, MA)
- …Market + Track record of successful cross-functional collaboration + Familiarity with global regulatory environments and requirements + Experience in lifecycle ... **Job title** **_:_** Global Medical Senior Director Dermatology and...engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs … more
- Sanofi Group (Cambridge, MA)
- **Job title:** Senior Global Medical Director Ophthalmology **Location:** Cambridge, MA **About the Job** In order to pursue Sanofi's purpose of "Chasing the ... engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs ...that address highest unmet needs. We are an innovative global healthcare company, committed to transforming the lives of… more
- Cole-Parmer (Franklin, MA)
- …product line development in collaboration with Research & Development, Operations, Regulatory Affairs and Commercial teams. Implement appropriate programs to ... Job Title: Senior Product Manager, Job Title: Senior Product Manager, Global Product Management Reports To: VP, Global Product Marketing, ZeptoMetrix… more