- Unknown (Boston, MA)
- …guidance to the client contact for CMC development teams. The Director will also lead regulatory intelligence activities, monitoring changes in regulations ... The Director will collaborate cross-functionally with internal teams to ensure alignment of CMC regulatory strategies with overall development plans and… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position?** Reporting to the Director in Organon Regulatory CMC ,?the Associate Principal Scientist is responsible for?developing ... for assigned products across the product lifecycle. + Identify,?communicate?and escalate?potential regulatory issues to Organon Regulatory CMC management,… more
- Formation Bio (New York, NY)
- … documents, eg, INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant regulatory filings. Provides Regulatory CMC guidance around drug ... new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and directing… more
- Merck & Co. (Rahway, NJ)
- …development through commercialization, with practical insight into how these operations generate CMC regulatory content Understanding of CMC operations, ... transfer of process and product knowledge with reduced error ratesDigital CMC will implement digital solutions to install the foundational capabilities needed… more
- Formation Bio (New York, NY)
- …more efficiently.About the PositionFormation Bio is seeking a motivated, experienced Director , Formulation Development to join our dynamic team. This critical role ... will report to the VP, CMC and will be responsible for leading formulation development...technical expertise, strategic thinking, leadership capabilities, and a strong regulatory and industry knowledge base in pharmaceutical sciences or… more
- Formation Bio (New York, NY)
- …where you will work closely with our business development, legal, clinical, CMC , and data/engineering teams to on-board products with strong IP potential, and ... thereafter coordinate patent and regulatory activities to deliver best-in-class IP positions. We expect this person to create and influence strategy, assist with… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …commercial strategy.Collaborate closely with internal functions such as Pharmacology, CMC , Regulatory Affairs, Clinical, and Program Management.Maintain ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Director of Toxicology as part of the Clinical Development team based in… more
- Insmed Incorporated (NJ)
- …maintenance, to ensure robust supply tracking and randomization supportCollaborate with CMC , Clinical Ops, Quality, Regulatory , and Commercial Supply teams ... and for the future of science, we're in. Are you?About the Role:The Director of Clinical Supply Chain Operations is responsible for leading global demand planning… more
- Formation Bio (New York, NY)
- …from initial evaluation to pre-close. Coordinate cross-functional workstreams (Clinical, CMC , Regulatory , Nonclinical, QA, Commercial, Finance, Legal/IP). ... faster and more efficiently.About the PositionFormation Bio is seeking an Associate Director , Program Management - Asset Diligence & Integration to partner with our… more
- Insmed Incorporated (NJ)
- …what's possible for patients with serious diseases. Reporting to the Associate Director , Regulatory Affairs, Tactical Implementation, you'll have a critical role ... Nonclinical, CMC ) to ensure effective coordination and execution of regulatory deliverables Monitor new regulations and guidelines to ensure internal processes… more
