Enzene Biosciences Ltd. Hiring for Domestic/ROW Regulatory Function at Executive & Senior Executive level – Apply Now
Enzene Biosciences is Hiring!!
Domestic/ROW Regulatory Function at Executive & Senior Executive level
QUALIFICATIONS : M.Sc/M. Pharm/M.Tech (Biotechnology) with 1 to 5 years of experience in Regulatory Affairs
KEY RESPONSIBILITIES :
• Preparation of dossier for PCS, CTA, MAA and Post Approval Changes
• Coordination with different internal stakeholders and departments for regulatory documents.
• Responding to queries from DCGI/RCGM/State FDA on dossier application.
• Preparation of dossier for ROW markets (ICH, formats CTD, ACTD), Life cycle management of products for ROW markets (Filing, renewal, post approval, amendment etc).
• Submission of documents to Indian Regulatory authorities (DCGI) for CT NOC, Test-license, Import license, Notifications, Amendment etc, through Sugam portal.
Tracking of the project’s approval, acknowledgement copies and Notifications from DCGI.
• Real Time updation of registration status of respective products/countries and to maintain the registration of the products
Refer to the detailed job profile below and if found suitable you can apply by clicking on the link – https://bit.ly/3M1mvQh
