- Insmed Incorporated (NJ)
- …each other, and for the future of science, we're in. Are you?About the Role:The Sr. Director CMC QA will lead QA CMC oversight for drug products, biologics, ... of deviations, CAPAs, change controls, and protocols/reports.Collaborate cross-functionally with CMC team, Regulatory, Clinical Operations, and Program Management to… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs, CMC will be responsible for reviewing the CMC ... changes, providing regulatory impact assessments, and coordinating with regional RA- CMC leaders to formulate regulatory strategies for post-approval changes. This… more
- Insmed Incorporated (NJ)
- …Are you?About the Role:This position is a key role that will provide regulatory CMC (RA CMC ) leadership and strategy to achieve regulatory approvals in various ... countries. As a strategic function, RA CMC is required to collaborate closely with multiple functions...regulatory strategies and identify the gaps and challenges of CMC development to ensure the approvability of the drug… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position?** Reporting to the Director in Organon Regulatory CMC ,?the Associate Principal Scientist is responsible for?developing ... and?implementing Regulatory Chemistry, Manufacturing & Controls ( CMC ) strategies for?assigned?small molecule products in accordance with global regulations… more
- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and directing the ... supplemental NDAs/BLAs and other relevant regulatory filings. Provides Regulatory CMC guidance around drug development and manufacturing/supply processes Understands,… 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 ... Comfortable working cross functionally, including partnering with clinical and CMC teams to identify patentable innovations during development, collaborating with… more
- Merck & Co. (Rahway, NJ)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... packaging activities as well as supply chain documentation to support critical CMC activities. Support the collection of clinical supply chain metrics and/or… more
- Merck & Co. (Rahway, NJ)
- …pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research ... Commercial Manufacturing groups. The candidate should be capable of leading a cross-functional CMC team and is expected to be adept in managing work with external… more
- Insmed Incorporated (San Diego, CA)
- …and for the future of science, we're in. Are you?About the Role:The Director , Regulatory Affairs will serve as the regulatory leader on cross-functional teams, where ... senior leadership, as neededCollaborate with Clinical Development, Clinical Operations, CMC , QA/QC, Nonclinical, Program Management, and external consultants to… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …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 ... NJ. Role OverviewWe are seeking a highly experienced and strategic Senior Director of Toxicology to lead and oversee all nonclinical safety assessment activities… more
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