Senior Manager - Regulatory Affairs - DCGI - Pharma

Senior Manager - Regulatory Affairs ( DCGI ) at Pune with Top Pharma Company.

We have come Up with new fresh career opportunity at Pune with leading Pharma company as "Sr.Manager Regulatory Affairs - DCGI.

1) Candidate must have experience in pharmaceutical Regulatory Affairs - DCGI with Reputed Pharma company.

2) Experience in Pharmaceutical research & development of products for India market. Regulatory affairs, Management of R&D facility operations, Contract Manufacturing liaison & Coordination.

3) Technical concepts, research work & documentation as per pharmaceutical industry regulations & various other regulatory authorities in an effective manner .

4) Knowledge of product approvals from Local FDA and DCGI for India and export markets.

5) Hands on experience on documentation requirements of local FDA Test license, DCGI Import/ export Licenses, Narcotic NOCs and DSIR approval of R&D site.

6) Development and execution of regulatory strategies for the new product for commercial launch. Knowledge of drafting registration documents/ dossiers as per ICH guidelines, export ROW market and DCGI for India market.

7) Knowledge of drafting documents for pharmaceutical development report, process validation and technology transfer activities.

8) Resolving issues related new product transfers, TPO transfers & undertaking initiatives related to maintenance of existing marketed products. & Identify product weakness and propose a specific remediation plan including cost and timelines. Align key stakeholders and get appropriate support for execution.

Ashish Kadam
HR Executive
KonnectHR Executive Search Firm