- J&J Family of Companies (Boston, MA)
- Associate Director , CMC Regulatory Affairs - 2406221330W **Description** Johnson & Johnson is recruiting for an Associate Director , CMC Regulatory ... of development and commercialization. This person is responsible for developing global CMC regulatory strategies. The primary responsibility is to work on… more
- Actalent (Boston, MA)
- *Gene therapy experience preverred* Responsibilities: + Actively represent Regulatory CMC and provide regulatory expertise as a member of interdisciplinary ... to agency questions, and maintenance activities. + Coordinate and drive regulatory CMC submissions, including assembling necessary cross functional teams… more
- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + Independently ... life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Small Molecules where you...where you will oversee the development and execution of regulatory CMC development and registration strategies. RA… more
- Takeda Pharmaceuticals (Boston, MA)
- …the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will ... therapies to patients worldwide. Join Takeda as a Senior Director , GRA CMC Pharmaceuticals Development Portfolio Lead...CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.… more
- Takeda Pharmaceuticals (Boston, MA)
- …Establish collaboration with Takeda teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives on drug-device ... product role in pharmaceuticals and/or medical devices industry including experience in regulatory CMC ; international experience is a plus + Experience working… more
- Takeda Pharmaceuticals (Boston, MA)
- …knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking an Associate Director , CMC Program Lead, Cell Therapies in Cambridge, MA with ... and product quality improvement in Chemistry, Manufacturing & Control ( CMC ) processes; Employ technical project management principles (project planning, RACI,… more
- Takeda Pharmaceuticals (Boston, MA)
- …a network of company Subject Matter Experts across Global R&D (Pharmaceutical Sciences, CMC Regulatory Affairs & Devices), Global Manufacturing Supply and Global ... events. + He/she must have a depth of experience in defining global Regulatory CMC strategy, superb collaboration skills, rapid, disciplined decision making and… more
- Merck (Boston, MA)
- …pivotal leadership role within the organization, overseeing the quality assurance and regulatory CMC for complex medical devices, including auto-injectors and ... **Job Description** The Executive Director , Device Quality & Regulatory will...oversight of product validation, verification, and risk mitigation activities. Regulatory CMC Oversight + Lead the preparation… more
- Merck (Boston, MA)
- …final guidance and standards. + Provide strategic advice to senior management on CMC regulatory matters based on health authority feedback and global ... collection and analysis of data for management review. **Reports to** - Director Regulatory Compliance, Device Quality and Regulatory **Location** - Remote,… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as a Director , Pharmaceutical Sciences Program Leadership where you will be responsible for ... Sciences Early-Stage Portfolio team, you will report to Pharmaceutical Sciences ( CMC ) Early-Stage Portfolio Leader and mentor and cultivate best practices in… more
- Sanofi Group (Cambridge, MA)
- …an **Analytical Development Director ** to lead the analytical group in our CMC function at Cambridge Crossing site, which is part of the synthetic platform ... **Job Title:** Analytical Development Director + **Location:** Cambridge, MA **About the Job**...within Global CMC Development. We are striving to become an industry… more
- Takeda Pharmaceuticals (Boston, MA)
- …Provides strategic scientific leadership and program management for multiple global CMC development teams dealing with complex development programs that require ... as functional expert in divisional and cross-divisional initiatives. + Represents CMC on cross-divisional governance and development teams while providing strategy… more
- WuXi AppTec (Boston, MA)
- …needs in TIDES drug development from discovery through clinical to commercial. Moreover, our Regulatory Affairs CMC team is experienced in preparing CMC ... drug). We greatly simplify the TIDES drug development by providing all discovery, CMC development and the entire manufacturing supply chain under one roof. With over… more
- Novo Nordisk (Lexington, MA)
- …Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing ... + Work with, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive the… more
- Sanofi Group (Waltham, MA)
- **Job title: Director Non-clinical Biostatistics - Vaccines** + Location: Swiftwater, PA or Waltham, MA (must have ability to work onsite 2-3 days per week per ... Join our Translational and Nonclinical Biostatistics team in Sanofi Vaccines as the ** Director of Non-clinical Biostatistics** where you will lead a team of experts… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …their teams in the field of analytical controls and compliance + Global CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight of all ... Contribute to overall functional direction globally and represent function within CMC /Pharmaceutical Science and across the global Takeda organization. + Implement… more
- Organon & Co. (Boston, MA)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs, chemistry, manufacturing and control ( CMC ), project ... position can be 100% remote in the US** The Director , Translational Medicine and Early Development (TMED) Lead will...are sound, based on the most up-to-date literature and regulatory guidances and support the approved early development plans.… more
- Cardinal Health (Boston, MA)
- …of capacities, including: + Global Regulatory Strategy Development + Global Regulatory Affairs + Chemistry Manufacturing and Controls ( CMC ) Development + ... influencers. **Job Summary** For nearly five decades, our industry-trained regulatory consultants have provided expertise and guidance to help pharmaceutical,… more
- Takeda Pharmaceuticals (Boston, MA)
- …development functions. + Prepare and coordinate completion of technology transfer documentation, CMC sections of regulatory documents, or validation plans and ... and transfer; + Ability to design and direct analytical strategy to meet CMC project objectives. + Experience in preparing regulatory documentation. **More about… more
- Sanofi Group (Framingham, MA)
- …Coach a team responsible for preparing reports and other internal documentation for regulatory purposes. + Collaborate with MSAT and CMC Development colleagues ... **Job Title:** Associate Director , Upstream MSAT **Location:** Framingham, MA **About the...quality event management, and APR + Experience with authoring regulatory filings and supporting PAI and other health authority… more