Team Member - Regional RA

Job Purpose

Submit product documents to regulatory authorities in accordance with country specific regulatory requirements to ensure approvals and market launch in stipulated time and handle post-approval changes, maintenance, and updation of documents during the products life-cycle

Accountabilities

1. New Marketing Authorisation Application and Maintenance of European Marketing Authorizations belonging to Cipla group of companies in accordance with EU legislation.

2. Submission to approval of regulatory procedures viz. New MAA, variations, renewals, sunset clause, process licenses (MIA) by collaborating with Central Operations teams / Cross functional teams in line with business plans and with EU legislation.

3. Participating in forums discussing product supplies in collaboration with cross functional teams, providing regulatory input to achieve on time launch and uninterrupted supplies to market in line with business plans.

4. Maintain files / databases to reflect up to date filing to approval status by having internal systems to capture these online so that the business / cross functional teams have visibility of submission to approval status of the region. Report MA approval and updates to PV within timelines to allow compliance with PV legislation.

5. Support Group Leader/Team Leader-Europe in leadership reviews and discussions.

6. Attend trainings as scheduled in order to ensure successful filings of Regulatory applications.

7. Other works assigned by department heads.

Apply Link- Apply Link mentioned in below