- Robert Half Finance & Accounting (Morristown, NJ)
- …driving quality management initiatives. Responsibilities: * Ensure adherence to FDA Good Manufacturing Practices (GMP) and other regulatory standards within ... to play a key role in ensuring compliance with quality and regulatory standards within the pharmaceutical...Chemistry, or a related discipline. * Strong knowledge of FDA GMP regulations and quality management systems.… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …**Preferred Qualifications:** + Demonstrated success in the preparation and completion of regulatory submissions (Qsub, PMA, 510(k), IDE) to FDA and other ... global regulatory agencies and experience negotiating with regulatory authority personnel (eg FDA , Notified Bodies) preferred + Must demonstrate ability to… more
- Edgewell Personal Care (Allendale, NJ)
- …celebrate our shared achievements. **POSITION SUMMARY** The **Global Supply Chain Analyst - Regulatory & Quality (Data & Analytics Focus)** is responsible for ... delivering data-driven insights that support Regulatory and Quality functions across the global...Regulatory Affairs, or Operations Analytics + Exposure to regulatory standards such as FDA , EU MDR,… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- … Affairs Specialist assists in the preparation, review and submission of high quality , regulatory submissions such to the Food and Drug Administration ( ... Regulatory Affairs Specialist, assists in the management of regulatory submissions to ( FDA ) and other Health...in the management of regulatory submissions to ( FDA ) and other Health Authorities, as required, within company… more
- RWJBarnabas Health (West Orange, NJ)
- …years of legal experience, including substantial experience with clinical research, FDA regulatory compliance, and research contracting + Comprehensive knowledge ... Assistant Vice President of Legal Affairs, Clinical Research & Regulatory ComplianceReq #:0000206242 Category:Professional / Management Status:Full-Time Shift:Day Facility:RWJBarnabas… 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, ... implemented and maintained across the organization, as well as ongoing and future regulatory compliance planning and proof of cGMP. Lead the design of regulatory… 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
- Sumitomo Pharma (Trenton, NJ)
- …other tools used within the group. + Manages the planning, tracking, compiling, quality checking and submission of required FDA Submissions (eg Establishment ... and procedures, including computer word processing, electronic document management systems, and regulatory publishing software. + Robust understanding of FDA and… more
- System One (Florham Park, NJ)
- …Overview: This role will support in the preparation and submission of electronic regulatory documents through the FDA and Health Canada Electronic Submission ... documents for electronic submissions. + Coordinate with cross-functional teams, including Regulatory Affairs, Clinical Development, and Quality Assurance, to… more
- United Therapeutics (Trenton, NJ)
- …of biologic or pharma regulatory experience with a Bachelor's Degree in life sciences, quality , regulatory affairs or a related area of study or 10+ years of ... pulmonary arterial hypertension( **PAH)** . Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with... experience with a Master's Degree in life sciences, quality , regulatory affairs or a related area… more