Parexel Hiring Regulatory Affairs Consultant
- Experience in managing FDA regulatory submissions – IND, NDA, ANDA, Post Approval submissions for labeling.
- Developing labeling strategy and content and Coordinating reviews and artwork changes.
- Updating SPL and Manage drug listings.
- Global labeling experience in Post Approval Activities like CCDS filings, PRAC & PSUR submissions, any other labeling change originating from CMC.
6 -12 years of experience in Labeling.