- Lilly (Philadelphia, PA)
- …people around the world. **Position Overview:** The Associate Director - CMC Regulatory is responsible for leading global CMC regulatory activities ... to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work… more
- AbbVie (North Chicago, IL)
- …from regulatory authorities. + Leverage extensive drug development experience to lead the global cross-functional CMC Team in completion of global regulatory ... Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Leads global regulatory dossier preparation activities by coordinating cross-functional teams of… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …project development preferred - 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub...team and serves as ad hoc member to the Global Project Team for late stage projects. **This position… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** The Associate Director , Analytical Regulatory Science, collaborates with product development, ... analytical flexibility the incumbent will support "right first time" global approvals for CMC control strategies and maintain "right to operate" throughout the… more
- Regeneron Pharmaceuticals (Troy, NY)
- …and made available throughout IOPS + Monitors and assesses all sources of global CMC intelligence information, including industry trends, for relevance and ... The Director of CMC Industry and Regulatory...health, environment or politics or related degree and: + Associate Director : 15+ years of related experience… more
- Bristol Myers Squibb (Seattle, WA)
- …their personal lives. Read more: careers.bms.com/working-with-us . **Title: Sr. Manager / Associate Director , Global Sterility Assurance CTTO** **Location: ... BMS with our Cell Therapy team. T he **Sr Manager/ Associate Director - Sterility Assurance, Cell therapy...Sterility Assurance, Cell therapy technical Operations** reports to the Director , Global Sterility Assurance within the Technical… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC Portfolio Products, will be responsible for ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio… more
- Takeda Pharmaceuticals (Boston, MA)
- …true to the best of my knowledge. **Job Description** **Objective / Purpose:** + Global CMC program oversight of PS with management of all project-related ... + As PS Lead, lead PS Team as a liaison between the Global Product Team (member)/DDU and CMC sub-team leads; evaluate and escalate risks/issues from a CMC … more
- Bristol Myers Squibb (Summit, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Title: Associate Director , Cell Therapy Comparability** **Location: Summit, NJ or ... and the ability to help patients are incredible. The ** Associate Director , Cell Therapy Comparability** will lead...manufacturing, quality, regulatory, etc., and key matrix leaders from CMC and Global Operation teams. Additionally, they… more
- Merck (Rahway, NJ)
- **Job Description** Under minimal guidance of the Executive Director / Director / Associate Director , Pharmacovigilance (PV) Partner Strategy & Management ... partner and vendor PV agreements and leadership of the Global Clinical Safety & Pharmacovigilance (GCS&PV) implementation activities for...and SMPs. + Maintains, in collaboration with the Executive Director / Director / Associate Director … more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Outsourcing & Vendor Management Pleasanton, CA, USA * Princeton, NJ, USA Req #385 Friday, August 16, 2024 Looking for a chance to make a ... we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other....dynamic and expanding mid-size company in the role of Associate Director , Outsourcing and Vendor Management. Your… more
- Ascendis Pharma (Palo Alto, CA)
- …a dynamic workplace for employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be responsible for developing and ... implementing global regulatory strategies encompassing clinical, non-clinical and ...team (specifically from: Talent Acquisition Partner or Human Resources Director ) is not allowed. If this occurs your ownership… more
- BeiGene (Emeryville, CA)
- **General Description:** The Associate Director , DP Commercial Small Molecule in External Supply Quality organization is responsible for ensuring the commercial ... regulatory expectations and applicable GMP/GDP quality standards. The role has global responsibility and accountability for commercial product quality for global… more
- Takeda Pharmaceuticals (Lexington, MA)
- …to the best of my knowledge. **Job Description** **Objective / Purpose:** As an Associate Director in Analytical Development, it is expected that the individual ... processes within the department and influencing scientific and process improvement in global AD. + Strong knowledge of ICH and other regulatory guidelines including… more
- Merck (North Wales, PA)
- …the Research & Division organization of our company. **Position Description/Summary:** The GPAM Associate Director , Project Manager, is a core member of Early ... Description** The drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in...& Development pipeline and realize its full potential. The Associate Director is expected to provide project… more
- AbbVie (North Chicago, IL)
- …GMP compliance strategies for the Analytical R&D (ARD) functions guided by global regulatory requirements, while effectively managing local and global interfaces ... across Small Molecule and Biologics Analytical R&D functions (SMARD/BARD), CMC Regulatory Affairs (RA), Quality Assurance (QA), CMC Coordination, Product… more
- CSL Behring (King Of Prussia, PA)
- …used to treat serious and often rare conditions. Could you be our next Associate Director , R&D Project Planning Capability Lead? This position is located in ... CSL Behring is a global biotechnology leader, guided by a promise to...Prussia PA office. It is a Hybrid role. The Associate Director , R&D Project Planning Capability Lead,… more
- Bristol Myers Squibb (San Diego, CA)
- …RayzeBio aims to be the global leader in radiopharmaceuticals . The Director / Associate Director of Radiochemistry will lead the Discovery Radiochemistry ... modalities such as peptides, small molecules, and antibodies. The Director / Associate Director will also be...teams. + Ability to partner effectively with clinical, regulatory, CMC development, biology, and DMPK teams to ensure successful… more
- CSL Behring (King Of Prussia, PA)
- …used to treat serious and often rare conditions. Could you be our next Associate Director R&D Business Operations? This position is located in our King ... CSL Behring is a global biotechnology leader, guided by a promise to...will manage direct reports. You will report to Sr. Director , Integrated Business Operations and R&D Chief of Staff.… more