- Taiho Oncology (Princeton, NJ)
- …Value Proposition: Join our dynamic and expanding mid-size company in the role of Director for Regulatory CMC directly reporting to Executive Director , ... Taiho Oncology Inc., (TOI) projects; provides strategic regulatory guidance especially for CMC during drug development , approval and post approval processes and… more
- AbbVie (Florham Park, NJ)
- …& Development (R&D) organizations. Represents CMC on teams such as product development , Global Regulatory Product Teams and Operations brand teams to ... requests. + Represents CMC regulatory affairs on teams such as the product development , Global Regulatory Product Teams and Operations brand teams,… more
- Organon & Co. (Jersey City, NJ)
- …Primary responsibilities include, but are not limited to: **Responsibilities** + Serve as the CMC Product Lead for assigned products and be accountable for the ... **Job Description** **The Position ** Reporting to the Director in Organon Regulatory CMC , the...of all regulatory milestones for assigned products through the product lifecycle. + Lead development and execution… more
- Atlantic Health System (Pompton Plains, NJ)
- …or hemolyzed blood according to approved procedures + Monitors blood and blood product inventory to ensure adequate supply for patient transfusion, orders blood and ... cost. This commitment is also echoed in the respect, development and opportunities we give to our more than...members. Offerings vary based on role level (Team Member, Director , Executive). Below is a general summary, with role-specific… more
- Sumitomo Pharma (Trenton, NJ)
- …FDA and ICH regulations/guidance documents specific to clinical research and general product development in the pharmaceutical industry + Experience reviewing ... with a minimum of 4 years focused in regulatory affairs + Oncology product development experience preferred + Experience contributing to electronic regulatory… more
- Merck (Rahway, NJ)
- …to product and process data + Streamlined transfer of process and product knowledge with reduced error rates Digital CMC will implement digital solutions ... these operations generate CMC regulatory content + Understanding of CMC operations, technology transfer, control strategy development , and regulatory… more
- Sanofi Group (Morristown, NJ)
- …with cross-functional teams to navigate complex regulatory landscapes, optimize product development and manufacturing processes, and directly influence ... **Job Title:** GRA Device Lead (Associate Director ) - Digital Health **Location:** Cambridge, MA/ Morristown,...review and approve design control deliverables. + Contribute to product development and lifecycle management planning. Provide… more
- Organon & Co. (Jersey City, NJ)
- …, regulatory affairs, safety and pharmacovigilance, Chemistry, Manufacturing and Controls ( CMC ), medical affairs and business development are critical to ... oversee non-clinical activities and safety assessments for Organon Research and Development (R&D) programs ranging from discovery through late-stage development .… more
- Organon & Co. (Jersey City, NJ)
- …in written format. + Track record of effective functional representation on product development teams. + Excellent verbal and written communication skills. ... **Job Description** **The** **Position** The Director , Clinical Pharmacology Lead will be responsible for contributing and/or devising the clinical pharmacology… more
- Organon & Co. (Jersey City, NJ)
- …guidance on the pharmacokinetic performance of drug products during formulation development and the drug product life cycle, including interpretation ... knowledge-sharing events. + Contribute to and/or review the nonclinical, early clinical development or CMC documentation to support regulatory or other… more