Assistant / Manager – Regulatory Affairs – Mumbai

From 6 to 10 year(s) of experience
₹ Not Disclosed by Recruiter

Job Description

JOB DESCRIPTION


1. Brief knowledge about MAs/ Formulation dossier filings of Drug products for successful approvals in ROW markets particularly AFRICA continent

2. Adequate knowledge of eCTD submission of formulated dossiers

3. Review and approval of Technology Transfer Documents / Site documents of New products, new projects

4. Close Coordination & follow up with internal & external stake holders for fast track submissions & approvals

5. Response to regulatory authority notices and quarries in time

6. Assist plant teams in regulatory audits, liaison with domestic & export regulatory authority.

7. Packing material (Art - work) recommendations and approvals as per regulatory provisions.

8. Ability to handle special & time bounded projects effectively

9. Ability & competency in handling external regulators directly

10. Willingness to travel abroad to interact with FDA regulators directly to bridge the gaps & to resolve issues.

Role:Regulatory Affairs Compliance

Salary: Not Disclosed by Recruiter

Industry:Pharmaceutical & Life Sciences

Functional Area:Legal & Regulatory

Role Category:Corporate Affairs

Employment Type:Full Time, Permanent

Education

UG:B.Pharma in Pharmacy

PG:M.Pharma in Pharmacy

Doctorate:Ph.D/Doctorate in Pharmacy

Company Profile

Hetero Drugs Limited

M/s. Hetero Drugs Ltd is one of the Largest Pharmaceutical Company in India.
Company Info
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Contact Company:Hetero Drugs Limited

Address:7-2-A2,,,Hetero Corporae,Industrial Estate,Sanath , Nagar, Hyderabad, Telangana, India

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