- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + ... immune disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team...Acts as point of contact for cross-functional teams on RA labeling issues. Based on timelines or… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Represents RA Ad/Promo at Regulatory Project Team meetings. + Represents RA Ad/Promo at labeling meetings and provides strategic regulatory guidance. ... Join Gilead and help create possible, together. **Job Description** Regulatory Advertising and Promotion ( RA Ad/Promo) is... Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a… more
- Bausch Health (Bridgewater, NJ)
- …and procedures to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to ... your skills and values drive our collective progress and impact. The Associate Director , Advertising and Promotion, Prescription Drug Products, reviews, approves… more
- Merck (Rahway, NJ)
- **Job Description** We are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can ... advance our pipeline and drive our strategic priorities. The Director , Principal Scientist | Regulatory Affairs...by global regulatory agencies. + Reports to Associate Vice President, Executive Director , or Senior… more
- Merck (Rahway, NJ)
- …We are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help ... **Summary, Focus and Purpose** The Senior Principal Scientist | Regulatory Affairs Liaison is responsible for development...external to GRACS. **Key Functions** + Reports to Executive Director or Associate Vice President, General Medicine… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs ( RA ) CMC project representative to the CMC ... manager. + ** Regulatory Knowledge:** Demonstrates expert knowledge of US/EU regulatory guidances. Serves as RA CMC representative supporting company… more
- System One (Florham Park, NJ)
- …regions, and provide insights to the Senior Director and Associate Director . + Contribute to managing regulatory risks and opportunities related to QOL ... Senior Manager, Regulatory Affairs (BRANDED PRODUCTS) Must be...(QOL), plays a pivotal role in supporting the Senior Director in overseeing regulatory activities related to… more
- WuXi AppTec (Cranbury, NJ)
- …in TIDES drug development from discovery through clinical to commercial. Moreover, our Regulatory Affairs CMC team is experienced in preparing CMC dossiers to ... any scale. Beyond chemistry, we offer formulation development, drug product manufacturing, labeling and distribution services in a variety of injectable dosage forms… more