- Cardinal Health (Trenton, NJ)
- …Review Standards + Drug, Biologic (IV, Injectable) and Medical Device Development + Regulatory Outsourcing + Pharmaceutical Compliance + Product Lifecycle ... **Position Summary** For nearly five decades, Cardinal Health Regulatory Sciences' industry-trained regulatory consultants have provided expertise and guidance… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …years with focus on pharmaceutical regulatory affairs, incl. familiarity with regulatory compliance frameworks (eg, ICH, FDA, EMA) (Required) + 2 or more ... processes on a consistent basis and identifying areas of potential non- compliance or operational risks. **Responsibilities:** + Maintain regulatory procedural… more
- New Jersey Institute of Technology (Newark, NJ)
- …preferred. - Expertise in curriculum development, program assessment, and industry regulatory practices/ compliance . Bargaining Unit: PSA FLSA: Exempt Full-Time ... Title: Professor of Practice - Pharmaceutical Chemistry Department: Chemistry and Environmental Science Reports...& Environmental Science seeks a Professor of Practice in Pharmaceutical Chemistry to serve as the graduate program director… more
- AbbVie (Florham Park, NJ)
- …the Clinical Development process for Phase I-IV or extensive knowledge of Pharmaceutical Development including compliance and regulatory requirements. Must ... with Global Medical teams, Clinical Development, Commercial, Market Access, Regulatory , HEOR and other functional areas, provides leadership, oversight, and… more
- Bausch Health (Bridgewater, NJ)
- …progress and impact. The Associate Director, Regulatory Affairs handles regulatory development and post-approval/ regulatory compliance for assigned ... assigned pharmaceutical products. + Coordinate/Liaise with BHC country-specific pharmaceutical Regulatory Affairs personnel for international submissions and… more
- Bausch Health (Bridgewater, NJ)
- …for successful filing, approval, registration, market launch, maintenance of business and regulatory compliance . + Active member of product development team(s) ... of assigned portfolio. Active member of the product development team to provide regulatory guidance for pharmaceutical products. Manages relevant regulatory … more
- Bausch Health (Bridgewater, NJ)
- …and impact. The Senior Specialist Regulatory Affairs executes on the pharmaceutical regulatory strategies for assigned brand products. Supports for Brand ... compliance . Key Responsibilities: + Provide support for the execution of the pharmaceutical regulatory brand strategy for assigned products + Support … more
- Sanofi Group (Morristown, NJ)
- …background in cloud technologies, batch data processing, real-time API integration, and regulatory compliance for pharmaceutical or healthcare systems. The ... between validated and non-validated systems, ensuring data flows smoothly while adhering to regulatory compliance (21 CFR Part 11, FDA REMS guidelines). + Work… more
- Sanofi Group (Bridgewater, NJ)
- …background in cloud technologies, batch data processing, real-time API integration, and regulatory compliance for pharmaceutical or healthcare systems. The ... between validated and non-validated systems, ensuring data flows smoothly while adhering to regulatory compliance (21 CFR Part 11, FDA REMS guidelines). + Work… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …assigned project teams, to ensure Otsuka's products are developed/maintained in compliance with global regulatory requirements and guidances. Primary ... all CMC and GMP related documents for submission to regulatory authorities to assure compliance with ...programs (Word, Excel, PowerPoint, and Outlook). + 7-years CMC regulatory experience in the pharmaceutical industry with… more