- Sanofi Group (Morristown, NJ)
- …was possible. Ready to get started? **Main Responsibilities:** + Develop global regulatory CMC strategies and risk assessments for development projects and/or ... that impact the company + Identify, communicate, and manage resolution to routine/complex regulatory CMC issues. Articulate the implication of issue to project… more
- Organon & Co. (Jersey City, NJ)
- …assigned products across the product lifecycle + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC management, as ... project timelines. **Preferred Experience and Skills** A candidate with experience in Regulatory CMC in clinical development, initial marketing application and… more
- Bausch + Lomb (Trenton, NJ)
- …in assigned due diligence activities for business development and acquisitions. + Lead all CMC regulatory activities for IND, NDA, ANDA, and BLA submissions. + ... business outcomes. **Responsibilities:** + Formulate, lead, and drive integrated regulatory strategies across CMC and clinical/non-clinical, labeling, adpromo… more
- Bausch + Lomb (Trenton, NJ)
- …strategies across CMC and clinical/non-clinical, labeling, adpromo domains + Lead all CMC regulatory activities for IND, NDA and ANDA submissions and OTC ... reporting, administrative documentation, due diligence, market expansion, labeling content, regulatory compliance, regulatory intelligence and change management… more
- System One (New Brunswick, NJ)
- …candidates should have at least 2 years of experience specifically for Regulatory CMC documentation within the pharmaceutical or biotechnology industry. ... sections aligned with regulatory strategy for clinical and life-cycle CMC regulatory submissions and responses to health authority questions based on high… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …of drug candidates through appropriate formulation strategies. + Support preparation of CMC regulatory documents. + Support departmental initiatives for assigned ... approaches, and cGMP principles. + Experienced in building the CMC dossier for regulatory submissions within the development section as an author/reviewer. Basic… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical ... compliance with FDA, EMA, and Health Canada regulations. Assess regulatory impact of changes in CMC procedures...regulations. Assess regulatory impact of changes in CMC procedures and oversee internal regulatory guidance… more
- Sanofi Group (Morristown, NJ)
- …in early and late stage, development of multiple modalities; experience within regulatory CMC not directly applicable. + Demonstrated experience with preparation ... **Job Title:** Regulatory Strategist **Location** : Cambridge MA/ Morristown, NJ...accelerate progress. As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global… more
- Cardinal Health (Trenton, NJ)
- **_What Chemistry, Manufacturing & Control ( CMC ) contributes to Cardinal Health_** The _Scientist I, Chemistry, Manufacturing, and Control ( CMC )_ ensures ... efficient and quality production of product submission dossiers for Cardinal Health's Regulatory Science clients. Working remotely under the supervision of the … more
- Sanofi Group (Morristown, NJ)
- …within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global Research ... and Development. Sanofi's global regulatory affairs (GRA) function is comprised of more than...Lead for Specialty Care Combination Products will oversee key regulatory activities and report to the GRA Device Team… more
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