We have an urgent opening for AM/DM Regulatory Affairs for Nashik location for our leading pharmaceutical client

Qualification : Msc/Mpharma(Regular)

Experience required : minimum 10 years

Job location : Nashik

Job Responsibilities :

- Review and Submission of Drug Master File (DMFs) for US, EU & Japan, Submission of Certificate of Suitability (CEPs) dossier for EDQM, DMFs for Health Canada and Updates.

- Handling of deficiencies raised by FDA during the course of reviewing of the USDMFs as well as deficiencies raised by EUs during the course of reviewing of the EDMFs under Centralized (CP), Decentralized (DCPs), Mutual Recognition Procedures (MRP) and National Procedures.

- To ensure the Regulatory Compliance across the manufacturing site.

- Review of Change Controls for their impact on the respective Regulatory submissions.

- Interaction with Global customers regarding various Regulatory issues related to submission of Applicants Part of Active Substance Master Files [ASMFs] Under MAA.

- Evaluation of starting materials for their adequacy with respect to Regulatory submission.

- Handling of Questionnaires of various customers & regulatory authorities.

- Review and evaluation of Stability Data for Regulatory Submissions.

- Preparation and review of SOPs related to Regulatory Affairs.

- Candidate should have good experience only from API

Salary : Not Disclosed by Recruiter

Industry : Pharma / Biotech / Clinical Research

Functional Area : Legal, Regulatory, Intellectual Property

Role Category : Drug Regulatory Affairs/Documentation

Role : Regulatory Affairs Manager

Keyskills : Regulatory Affairs

Education : B.Pharma - Pharmacy, B.Sc - Any Specialization

PG : MS/M.Sc(Science), M.Pharma - Pharmacy

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