- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the ... supervision. Acts as point of contact to cross-functional teams on US/EU RA CMC project issues.Execution of Strategy and Submissions: Develops strategy with… more
- Aequor (Thousand Oaks, CA)
- …for product manufacturing and quality programs throughout product lifecycle. Title: Regulatory Project Coordinator (RPC)Job Description: o Assist Regional ... a mixed background not just lab but manufacturing and process development. This manager position within CMC will facilitate product development and global… more
- BeiGene (San Mateo, CA)
- …of regulatory applications. **Essential Functions of the Job:** + Serve as the regulatory CMC representative on project teams. Provides CMC ... **General Description:** + The Manager , Regulatory Affairs CMC ,...and guidance for assigned projects and interfaces with R&D, Project Management, Manufacturing, Quality, and Regulatory colleagues,… more
- Astellas Pharma (Westborough, MA)
- ** Regulatory Manager , Regulatory Affairs - CMC (Gene Therapy)** Do you want to be part of an inclusive team that works to develop innovative therapies ... remote work are encouraged to apply. **Purpose and Scope:** Responsible for developing regulatory CMC strategy for assigned projects. Identifies and collects … more
- Sanofi Group (Bridgewater, NJ)
- …( CMC ) Team as a Manager and you'll develop the Global Regulatory CMC strategies for development and marketed products within Global Regulatory ... **Job title:** Manager , Regulatory Affairs CMC ...**Job title:** Manager , Regulatory Affairs CMC - Vaccine +...other parts of GRA + Provide Regulatory CMC leadership, guidance, and coordination to project … more
- Takeda Pharmaceuticals (Columbus, OH)
- …**Job Description** **About the role:** We are seeking a highly motivated and qualified regulatory CMC professional for the Global Regulatory Affairs CMC ... CMC & Device organization is responsible for global CMC regulatory strategies and activities for the...the communication and flow of regulatory information ( regulatory framework, scope and project timelines) to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …35 countries worldwide, with headquarters in Foster City, California **About the role:** The CMC Regulatory Affairs Sr. Manager at Gilead is responsible for ... other Health Authorities for CMC -related topics (including management of regulatory deliverables and commitments) + Ensures project teams, line management,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the ... point of contact to cross-functional teams on US/EU RA CMC project issues. + **Execution of Strategy...Leads US FDA/EU EMA interactions with support from higher-level manager . + ** Regulatory Knowledge:** Demonstrates expert knowledge… more
- Frontier Medicines (South San Francisco, CA)
- Join Frontier Medicines on an exciting journey as our newest Senior Manager /Associate Director in CMC Development, located at either our Boston or South San ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...cultivating vendor relationships + Supervising third-party activities and delivering project updates with recommendations Traits we believe make a… more
- West Pharmaceutical Services (Exton, PA)
- …latest guidance documents and current state-of-art standards/regulations. + Collaborate with regulatory lead(s), cross-functional project manager (s) and SMEs ... Sr. Specialist, Regulatory Project Mgmt Requisition ID: 66496...IEC 62304, ISO 11608), 21 CFR Part 820 and CMC regulatory requirements. + Experience in medical… more
- Ascendis Pharma (Palo Alto, CA)
- …strategic and operational regulatory input and support for cross functional ( CMC , non-clinical and clinical) collaboration with other project team members. + ... to all aspects of the business, from drug development to marketing. The Manager , Regulatory Affairs will be responsible for supporting and developing global… more
- BeiGene (San Mateo, CA)
- …for regulatory technology and submissions (eg, eCTD, IDMP, SPOR/DADI, PQ- CMC , SPL) and coordinate impact assessment on systems and relevant data elements ... RIM function at BeiGene drives strategies, implementation and management of regulatory technology and information, by collaborating with cross functional teams (RA,… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- Regeneron is seeking a Manager to join the Regulatory Intelligence Group! **In this role, a typical day might include:** The Regulatory Intelligence ... from assigned departments or functions within the organization's GxP framework. The Regulatory Intelligence Manager will also facilitate processes to hold… more
- Lilly (Indianapolis, IN)
- …Knowledge. Additionally, the role will interface outside the manufacturing site with Network Project Managers, CMC Project Managers, and DDCS Project ... teams towards an established timeline that meets customer requirements and supports CMC and Regulatory timelines + Responsible for Tech Transfer Plans/Reports… more
- BeiGene (Emeryville, CA)
- **General Description:** Sr. Manager /Associate Director, Supply Chain CMO Management & PM will own and enable the communication, coordinate tasks between the ... with Contract Manufacturers (CMO) + In partnership with Quality, CMC , Procurement, ensures that innovation, manufacturing performance, cost objectives and… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Ability to design and direct analytical strategy to meet CMC project objectives. + Experience in preparing regulatory documentation. **More about us:** At ... + Prepare and coordinate completion of technology transfer documentation, CMC sections of regulatory documents, or validation...representative or team lead). + Represent functional area on CMC project teams by communicating activities from… more
- System One (Warren, NJ)
- Job Title: Technical Transfer Project Manager Location: Warren, NJ/ Seattle, WA Hours/Schedule: Mon- Fri business hours Compensation: $73.00- $83.91 Type: ... Contract Overview Leading Pharmaceutical company looking for an experienced Technical Transfer Project Manager . Ideal candidates should have 5+ years experience… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …optimization, and supervision of other manufacturing activities at CMOs. + Work within the CMC group and with internal and external project teams for timely ... and respect in all we do, create and deliver. As part of the CMC (Chemistry, Manufacturing and Controls) team of ITCI, **the** **Senior Manager , Formulation… more
- CSL Behring (King Of Prussia, PA)
- …the biotechnology or pharmaceutical industry** **At least 4 years as a project manager leading and managing complex, cross-functional drug development ... opportunities for refinement, and implementing iterative improvements.** **Ensure that project planning processes adhere to quality standards, regulatory … more
- Merck (North Wales, PA)
- …Description:** **Senior Specialist, Project Management- Drug Development** The Senior Specialist, Project Manager is a core member of Early Drug Development ... simple projects independently or moderate-complexity assignments in conjunction with a partner project manager . Projects could span any therapeutic areas in… more
