- WuXi AppTec (Plainsboro, NJ)
- …STA Pharmaceutical, a WuXi AppTec Company, has an exciting opportunity for a ** Manager / Senior Manager , CMC Project Management.** This position ... will be responsible for managing DS and DP projects within STA. The position will lead the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical team, and business development team. The… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned project ... **Job Description** + Anticipate and develop strategies and/or contingency plans for CMC related scenarios in the areas of biologic/small molecule drug substances,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team ... (eg, US FDA and EU EMA) for assigned projects with support, on CMC matters. This position supports Health Authority Meetings (eg, preIND, EOP2, pre-NDA, Type… more
- J&J Family of Companies (Horsham, PA)
- …of America **Job Description:** We are searching for the best talent for a ** Senior Manager , Product Quality Integrator, Launch & Grow Biotherapeutics** , to be ... step of the way. Learn more at https://www.jnj.com/innovative-medicine. **Purpose:** The Senior Manager , Product Quality Integrator, Launch and Grow… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …questions and drive business strategy using advanced data science and analytics. The Senior Manager , Development to Launch Analytics will join a dynamic and ... that drive our enterprise forward. Reporting directly to the Associate Director or Senior Director, Development to Launch Analytics, you will play a pivotal role in… more
- Sumitomo Pharma (Trenton, NJ)
- …. **Job Overview** We are currently seeking a versatile and experienced Senior Manager - Associate Director level scientist with strengths in ... of drug metabolism and bioanalytic chemistry. This position will report to Senior Director of Clinical Pharmacology and Drug Metabolism. S/he will work across… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory ... plans, address global regulatory issues, health authority queries, and regulatory obligations. - Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs… more
- WuXi AppTec (Cranbury, NJ)
- …oligo and peptide discovery business along with cultivating these relationships into CMC for IND enable studies with our manufacturing (CDMO) business. The candidate ... will work within the North America discovery business development team to pursue new business leads in addition to follow ups on critical issues and aid in resolving customer inquiries. **Responsibilities** + Hunting and Prospecting for oligo and peptide new… more
- Bausch Health (Bridgewater, NJ)
- …development team for agency filing + Work with the Pharmaceutical Regulatory Brand Senior Manager to make certain all product documentation is developed in ... your skills and values drive our collective progress and impact. The Senior Specialist Regulatory Affairs executes on the pharmaceutical regulatory strategies for… more
- Integra LifeSciences (Plainsboro, NJ)
- …through Sunday. **SUPERVISION RECEIVED** Under direct supervision of the Senior Manager , Manufacturing. **SUPERVISION EXERCISED** Directly supervises weekend ... Packaging Operations is responsible for the skin packaging production activities for CMC (Collagen Manufacturing Center) to ensure the safety, efficacy, and quality… more
- BMO Financial Group (New York, NY)
- …to regulatory requests, as directed + Interact directly, and in coordination with senior management, with key regulators as required + Help to ensure best practices ... analysis that will help identify potential areas of concern/challenge in the US TP, CMC , ChiB, and NYB strategy + Work with colleagues across OCOO to identify… more