- Insmed Incorporated (NJ)
- …both clinical and commercial supply chains.Your responsibilities will include supporting global CMC regulatory strategies that align with our clinical and ... small molecule process chemistry, formulation, and analytical development.Demonstrated success in regulatory submissions and global CMC regulatory … 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 ... to development, registration and manufacturing of biopharmaceutical products in support of CMC applications Serves as corporate liaison with regulatory Health… 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 ... from early research through IND-enabling studies and into clinical development, ensuring regulatory compliance and scientific rigor in support of our pipeline of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …PPQ and comparability protocols and reportsServe as reviewer/author of a variety CMC sections or regulatory submissions, risk assessments, validation impact ... This effort will extend to participation in a variety of cross functional CMC and quality forums under the Joint Manufacturing Committee in the commercial governance… 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). ... preferred. Familiarity with term sheets, diligence workplans, asset integration, and regulatory /quality transitions a plus. Formation Bio is prioritizing hiring in… more
- Merck & Co. (Rahway, NJ)
- …(DCT) leader is-accountable for delivering a fully integrated stage-appropriate CMC development and commercialization strategy which yields the target commercial ... risks across all factors that may impact technical, operational & regulatory success or timelines. -Analyzes and develops innovative solutions to unforeseen… more
- Insmed Incorporated (NJ)
- … regulatory approvals.Deep understanding of vector biology (AAV, etc.), CMC requirements, and manufacturing for gene therapy.Strong leadership, communication, and ... highly experienced and visionary Vice President, Product Development - CMC , Gene Therapy and Large Molecules, to help us...large molecules pipeline from preclinical through clinical development and regulatory approvals. In this role you will be a… more
- Insmed Incorporated (NJ)
- …maintenance, to ensure robust supply tracking and randomization supportCollaborate with CMC , Clinical Ops, Quality, Regulatory , and Commercial Supply teams ... to ensure compliance with eTMF documentation and audit readiness activitiesSupport regulatory filings (IND/CTA/IMPD), act as SME during inspections, perform risk… more
- Insmed Incorporated (NJ)
- …Nonclinical, CMC ) to ensure effective coordination and execution of regulatory deliverables Monitor new regulations and guidelines to ensure internal processes ... in. Are you?About the Role:We're looking for a Manager, Regulatory Affairs, Tactical Implementation, on the Regulatory ...Manager, Regulatory Affairs, Tactical Implementation, on the Regulatory Affairs team to help us expand what's possible… 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
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