- 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
- Lilly (Indianapolis, IN)
- …determined to make life better for people around the world. **Position Summary:** The Associate Director , CMC Project Management will provide strategic and ... acumen to enable investment strategy optimization at both project and portfolio level. The Associate Director , CMC Project Management may also partner with… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** ** Associate Director , Analytical Regulatory Sciences, Systems & Operations in ... is a site based position located in Foster City, CA_** The Associate Director , Analytical Regulatory Science, collaborates with product development,… more
- AbbVie (North Chicago, IL)
- …development, quality and analytics is required. + Knowledge and experience with FDA and global regulatory requirements for CMC issues is required. + Ability to ... or functions or outputs of this position. Full time/dedicated responsibility for CMC leadership and project management for commercial and pipeline small molecule… 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
- 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
- Organon & Co. (Plymouth Meeting, PA)
- …Executive Director in Organon Regulatory CMC New Products, the Associate Principal Scientist ( Associate Director ) is responsible for Regulatory ... initial product registration activities in an efficient, agile manner. + Provide Regulatory CMC and oversight in developing global Regulatory CMC strategies… more
- Merck (Wilson, NC)
- **Job Description** **Description** The candidate will be part of our company's Global Regulatory & CMC organization supporting the Americas Site CMC team ... organization and our Manufacturing Division. Reporting to the Sr. Director , Americas Site CMC , this role will...that product is released in accordance with the established Global Marketing Authorizations. + Connects site and product strategy… more
- Takeda Pharmaceuticals (Boston, MA)
- …people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for ... everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver **_Better Health and… more
- WuXi AppTec (Natick, MA)
- …commercial. Moreover, our Regulatory Affairs CMC team is experienced in preparing CMC dossiers to support global filings for TIDES new drug applications. ... 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
- 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
- Sanofi Group (Framingham, MA)
- **Job Title:** Associate Director , Upstream MSAT **Location:** Framingham, MA **About the Job** We are an innovative global healthcare company with one ... you thought was possible. Ready to get started? The Associate Director position is part of the...documentation for regulatory purposes. + Collaborate with MSAT and CMC Development colleagues across the global biologics… 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
- Bristol Myers Squibb (New Brunswick, NJ)
- …highly motivated and experienced Business Operations Leader to join our team. The Associate Director of Product Development (PD) Operations, reporting into the ... on answering key business questions across the enterprise. In this role, the Associate Director of PD Operations is responsible for driving strategic capability… more
- Sanofi Group (Cambridge, MA)
- **Job Title: Associate Director Crystallization** **About the Job** We are an innovative global healthcare company with one purpose: to chase the miracles of ... The successful candidate will work in a cutting-edge scientific global crystallization department in Sanofi's R&D CMC ...scientific global crystallization department in Sanofi's R&D CMC Synthetic organization. The job is in Cambridge MA,… more
- Merck (Rahway, NJ)
- **Job Description** The Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
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