- MTF (Edison, NJ)
- …Assist with UAT planning and execution using policies, procedures, and technology related regulatory practices ( FDA 21 CFR 11 -validated systems, etc.). Ensure ... that requirements are implemented and tested per the acceptance criteria. + Ensure Pro activeness rather than Re activeness. Delivering high quality results in a timely fashion. + Responsible for troubleshooting issues to investigate, resolve and escalate… more
- Catalent Pharma Solutions (Bridgewater, NJ)
- …understanding of financial and business concepts. + Experience working to regulatory standards: FDA , Good Engineering Practice (GEP), Good Manufacturing ... Procedures (GMP) and Good Documentation Procedures (GDP). + Demonstrated problem solving and bias for action skill set. Demonstrated ability to define and execute a strategy while concurrently delivering to metrics and driving a culture change. + Excellent… more
- Robert Half Legal (Mahwah, NJ)
- …Certificate from accredited ABA-Approved Program preferred. Ideal experience: working with the FDA , DEA, and other regulatory agencies. Strong knowledge of ... contracting and legal procedures, particularly related to pharmaceutical contracts and nondisclosure agreements. Robert Half is the world's first and largest specialized talent solutions firm that connects highly qualified job seekers to opportunities at great… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director, Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ready to ... our teams accelerate progress. This individual will be responsible for providing regulatory review and approval of US promotional and other product and… more
- Vitalief (New Brunswick, NJ)
- …is a qualifying trial per CMS regulations, and assesses compliance with other regulatory requirements, including FDA and NIH guidelines. + Negotiates budgets ... trial billing administrative start-up, insuring clinical research billing and regulatory compliance. Collaborate with Finance to coordinate documentation of each… more
- Sumitomo Pharma (Trenton, NJ)
- …and procedures, including computer word processing, electronic document management systems, and regulatory publishing software. + Robust understanding of FDA and ... highly motivated, and experienced individual for the position of Senior Manager, Regulatory Operations, For assigned projects, the Senior Manager of Regulatory … more
- Edgewell Personal Care (Allendale, NJ)
- …the Global R&D organization who oversees all activities related to regulatory compliance across all Edgewell's brand portfolio. Responsible for assessing, ... across the organization, as well as ongoing and future regulatory compliance planning and proof of cGMP. Lead the...efficiencies. + Represent EPC before government authorities such as FDA , Health Canada, TGA and others. + Maintains understanding… more
- Actalent (Fair Lawn, NJ)
- …documentation for approval, ensuring adherence to Good Documentation Practices (GDP) and applicable regulatory requirements (eg, FDA , GMP). . Act as a liaison ... suppliers. The engineer ensures compliance with GMP, GDP, and regulatory standards while driving process improvements, supporting investigations, and managing… more
- United Therapeutics (Trenton, NJ)
- …daughter's pulmonary arterial hypertension( **PAH)** . Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... hearts. **Who you are** We are looking for a regulatory strategist who will advise on regulatory ...senior level employees **Preferred Qualifications** + Proficient knowledge of FDA regulations, including 21 CFR 1271 and 21 CFR… more
- Kelly Services (Bridgewater, NJ)
- …solutions to assure all advertising and promotional materials are in compliance with regulatory requirements and company policies. + Monitors FDA and FTC ... abreast of market promotional and advertising strategies. + Provide regulatory support as needed for FDA warning...+ Provide regulatory support as needed for FDA warning and untitled letters, FTC letters, and direct… more