- WuXi AppTec (Austin, TX)
- **Overview** The AD Project Manager will be responsible for managing projects within STA, WuXi's API, and Drug Product development and manufacturing division. Leads ... the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical team, and business development team.… more
- AbbVie (North Chicago, IL)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works ... Leads initiatives internal to RA CMC . + Represents CMC regulatory affairs on project initiatives with other functional areas to drive efficiencies across the… more
- BeOne Medicines (Emeryville, CA)
- …implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the assigned project to ensure on-time and high-quality global ... product complaints arise during product lifecycle for the assigned project . + Provide CMC regulatory review for...lifecycle for the assigned project . + Provide CMC regulatory review for clinical protocols and investigator brochures,… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Associate Director - CMC BioDPDM **Location** : Framingham, MA As Associate Director within CMC BioDPDM, you'll have the opportunity ... could turn the impossible into possible for millions. The Associate Director role is a key leadership...Director role is a key leadership role in CMC Biologics Drug Product Development and Manufacturing. You will… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Associate Director , Global Regulatory Project Management (AD, Global RPM) is a strategic leader responsible for translating and ... lifecycle. This role blends deep regulatory expertise with advanced project management skills, driving successful NDA/BLA/MAA submissions and ensuring… more
- Sumitomo Pharma (Honolulu, HI)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs (Oncology).** The Associate ... (HA) information requests. In addition, this position may represent GRA in project related meetings, develop regulatory strategy and provide regulatory input as… more
- AbbVie (North Chicago, IL)
- …and automation systems strategy and roadmap in alignment with department objectives and SM CMC R&D strategies. . Develop and revise project plans and budgets, ... ongoing basis . Provide guidance, technical advice, planning, and project management within SM CMC and with...advice, planning, and project management within SM CMC and with outside functions, consultants, and vendors. Support… more
- Novo Nordisk (Boulder, CO)
- …we are driving change. Are you ready to make a difference? The Position The Associate Director of Drug Product Manufacturing is accountable for all clinical drug ... About the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics. The CMC team works… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …true to the best of my knowledge. **Job Description** **About the role** As Associate Director , API Process Engineering, you will be Takeda's global expert for ... site leadership, Technical Services, Pharmaceutical Sciences, Global Quality, and Regulatory CMC . + Provide technical support to marketing applications for global… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** GRA Device Lead ( Associate Director ) - Digital Health **Location:** Cambridge, MA/ Morristown, NJ **About the Job** GRA Device Lead ( Associate ... of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The...GRA Device Lead for DHTs and SaMDs on assigned project teams (early phase, late stage and marketed products)… more