- Regeneron Pharmaceuticals (Troy, NY)
- Regeneron is currently looking for a Manager for our CMC Regulatory Sciences team. We are seeking a highly motivated and experienced regulatory ... of world (ROW, ex-US/EU) initial marketing applications. As a Manager , CMC Regulatory Sciences, a...determined based on qualifications relevant to the role. + Associate Manager : Requires 6+ years of relevant… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with 8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry ... Leads US FDA/EU EMA interactions with support from higher-level manager . + ** Regulatory Knowledge:** Demonstrates expert knowledge...experience and 4+ years direct or related CMC regulatory experience + Successful track record… 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...thorough understanding of ICH guidelines, GLP/GMP manufacturing, and related regulatory requirements is required + Ability to travel domestically… 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
- Schrodinger (Cambridge, MA)
- We are looking to hire a **Senior Manager / Associate Director of Clinical Pharmacology** to join us in our mission to discover and develop drugs that improve ... stakeholders including DMPK, translational medicine, clinical development, clinical operations, regulatory , CMC , and project management to ensure completion… more
- BeiGene (San Mateo, CA)
- **General Description:** The Associate Manager of Clinical Supply Chain manages drug supply activities related to planning, label development, label & pack, and ... and provide a high service level to internal stakeholders (eg Clinical Operations, Regulatory , Quality, CMC ). + Work with Clinical Operations to understand… more
- CSL Behring (King Of Prussia, PA)
- …knowledge in drug research, development and manufacturing processes of pharmaceuticals ( CMC , non-clinical, clinical, and regulatory ).** **Expert level skillset ... 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 our King… more
- Gilead Sciences, Inc. (Foster City, CA)
- …our team, **Biologics Pre-Pivotal Formulation and Process Development** , as an ** Associate Scientist** . The successful candidate will contribute to the development ... documentation practices. . Author technical documents such as protocols, reports, regulatory dossier, etc. and prepare data-focused presentations for internal and… more
- Takeda Pharmaceuticals (Boston, MA)
- …Previous drug development experience is preferred (eg Medical Affairs, Clinical Research, Regulatory , CMC , or other development related function) + Project ... order to enhance team effectiveness and efficiency, + The Associate Director works closely together with the Oncology Business...+ 5 to 7 years experience as a project manager leading complex pharmaceutical projects in a multi-disciplinary, global… more
- Novo Nordisk (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
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