Regulatory Affairs Executive/Sr Executive- Labelling

Job Description

Accountabilities: Responsible for preparation, review, filling and timely launch of labeling for new submissions and Life cycle management for Rx/OTC products in US and Canada. Role & responsibilities :- New Submissions: 1. Review and timely completion of Labeling for ANDA/ANDS dossiers for submissions and prepare and review response to Labeling deficiencies to secure approval. 2. Provide necessary feedback to team developing drug products using regulatory guidelines and communication with agencies that has impact on product labeling. Life-Cycle Management 3. Routinely tracking of RLD/CRP labeling updates from Agencys website and timely notifying concerned stakeholders for the same. Completion and coordinating commercial launch activities for new/existing approved Rx products for Sun Pharma/Acquired products, and Customers. To initiate/provide approval for Artwork Approval Sheets for commercialization of artworks through Artwork Management System (AMS). 6. Providing timely information of Artwork approvals through approval package upon receipt of approval and update the same based on renewals and variations. 7. Coordination with various departments for preparation of variation packages (specifically w.r.t labeling part) and submit the same to regional offices. 8. To raise Change Controls for approved drug products in Track wise for labeling supplements and to ensure completion of variation proposal/management in a timely manner. 9. To provide labeling inputs to MACR for PSUR. 10. To prepare Annual reports 11. Review regulatory filing impact of variations, change controls, deviations (wrt to Labeling) etc. Ensure reposition of comprehensive product information into repository.