Sr. Managers of Regulatory Affairs & Compliance / Parsippany, NJ
Provide strategic regulatory input & prepare content for regulatory strategic documentation. In partnership with labeling lead facilitate identification of US labeling & supportive strategy for labeling issues. Act as a key contributor for the preparation of responses to queries from FDA & review content. Work to ensure that regulatory submissions are done in a timely manner through the electronic gateway using Pharma Ready & DocuProof software. Travel 10-15% in U.S. and India to visit CMOs/Partners.
Send res to ThePharmaNetwork LLC, 339 Jefferson Rd, Ste. 101 Parsippany, NJ 07054