- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …documentation and product labeling in consideration of US, EU, and other global regulatory requirements. + Authors FDA submissions, EU technical files, and other ... product review and approval. + Point of contact for FDA , EU notified bodies, and other regulatory ...and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum… more
- Grifols Shared Services North America, Inc (Trenton, NJ)
- Would you like to join an international team working to improve the future of healthcare ? Do you want to enhance the lives of millions of people? Grifols is a global ... healthcare company that since 1909 has been working to...110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development,… more
- Sanofi Group (Morristown, NJ)
- …on organizational structure. **About You** **COMPETENCES** + Strong knowledge of global regulatory labeling requirements ( FDA , EMA, ICH) and lifecycle labeling ... **Job Title:** Director, Global Regulatory Affairs - Global Labeling Strategy **Location** :...labeling development and negotiation. We are an innovative global healthcare company with one purpose: to chase the miracles… more
- Integra LifeSciences (Plainsboro, NJ)
- …chance to do important work that creates change and shapes the future of healthcare . Thinking differently is what we do best. To us, change equals opportunity. Every ... patient outcomes and set new standards of care. The **Internal Auditor, Regulatory Compliance** will have an in-depth understanding and knowledge of appropriate GMP… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion **Location:** Cambridge, MA or Morristown, NJ **About the job** Are you ready to shape the ... be critical in helping our teams accelerate progress. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …education regarding customer complaint processing, MDR's, complaint report ability, and regulatory compliance. + Fills out decision trees when needed, after ... reviews and approves. + Generates MDR reports in accordance with BD procedures and FDA regulations. **To be successful in this role, you should be able to… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …compliance with US pharmacovigilance regulatory norm + Anchor drug safety regulatory inspection in US ( FDA regulatory agencies),participate in audits ... identify and respond to signal analysis, and submit to regulatory agency ( FDA /Health Canada) within timelines to...the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as… more
- Bayer (NJ)
- …timely and accurate implementation of new and revised labeling in accordance with FDA requirements and provides regulatory expertise and guidance for labeling ... and analyzes and evaluates requests for new or revised labeling initiated by FDA or Bayer HealthCare Pharmaceuticals and manages action required to implement;… more
- J&J Family of Companies (Raritan, NJ)
- … and clinical requirements for diagnostics development and commercialization, including global regulatory frameworks (eg, FDA , EMEA, PMDA). + Proven ability to ... Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where...within Heme, ensuring alignment with overall clinical development and regulatory activities. + Serve as the primary point of… more
- Sumitomo Pharma (Trenton, NJ)
- …and achieve goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, ... teams. Regulatory Interactions: + Prepare and present clinical data to regulatory agencies ( FDA , EMA) during IND submissions, clinical study reports, and… more