Enzene Biosciences Ltd. Hiring for Domestic/ROW Regulatory Function at Executive & Senior Executive level – Apply Now

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