Cipla - Senior Manager - Regulatory Affairs

- Accountability Cluster /Major Activities / Tasks :

- Coordinate with various internal stakeholders (IPD, Medical & Marketing) to collect docs / data for the following types of application for submission to DCGI

- Marketing Approval / Clinical trial / Bio-equivalence studies - for domestic market.

- Bio-equivalence studies / GCT for international market

- Registration of imported formulations & their manufacturing site (Sch DI & DII)

- Form 10 (Import) Licence.

- PSUR / SAE / ADR Submission (Pharmcovigilance)

- SEC presentation for getting CT / MA Support to Business & Finance - Price Monitoring

- Provide list of products due to price revision to Rx team / Finance team along with relevant analysis on a regular basis

- Take feedback from Rx team / Finance team, evaluate and take ahead for further pricing decisions Compliance

- As Per Checklist - Coordinate with various stakeholders to prepare an appropriate reply to the letter from the regulatory bodies

- Timely response to these letters

- Quality response to avoid further queries

- Prepare & submit relevant Forms to NPPA & and the same to be updated in Compliance site Support to Regulatory Affairs - DCGI Permissions

- Provide the necessary support to Regulatory Affairs team for framing appropriate document to DCGI

- Follow up and coordinate with regulatory bodies to get the required marketing authorization

- Timely response to these letters

- Quality response to avoid further queries Process Improvements in Areas of Operations - Third party approval process

- Regulatory approvals

- DPCO related process

Educational qualifications : B.Pharm, M.Pharm

Relevant experience : 10 - 15 years in Regulatory Affairs, Please note this is for Domestic Market only!