Assistant manager- Regulatory Affairs

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

Job Description

Roles and Responsibilities

1. Preparation and reviewing of CTD and ACTD dossier.

2. Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission.

3. Co-ordination with plant for Regulatory compliances.

4. Timely achievement of monthly plan & timely query response.

5. Gap Analysis/Updation of Master data.

6. Review of Change Controls, Stability Protocol, Clinical Trial Protocols & Artworks.

7. Get feedback from all the countries for respective variation, and their timely submission.

8. renewals.

9. Master data Updating.

10. Follow ups with plant for documentation regularly and review meeting.

11. Tracking and reviewing of document requirements of upcoming new filing in ROW and Emerging markets

Desired Candidate Profile

Candidate must have knowledge of eCTD, CTD, Validation, ICH requirements, USFDA Filings, WHO Prequalification, MCC South Africa for Biological and Biotech products.

Should have exposure to in-licensed dossier filing and out licensing.


Salary: Not Disclosed by Recruiter

Industry:Pharmaceutical & Life Sciences


Role Category:Other

Employment Type:Full Time, Permanent

Key Skills
Skills highlighted with ‘‘ are preferred keyskills


PG:MS/M.Sc(Science) in Biotechnology,M.Pharma in Any Specialization

Company Profile

Bharat Serums and Vaccines

About BSV

For over 5 decades now, we at Bharat Serums and Vaccines Ltd. have used our scientific resources to develop a range of biological, biotech and pharmaceutical products. Advent International, a global PE firm has endorsed its faith in our commitment towards bringing life to life and is partnering with us on an ambitious growth journey

Company Info
View Contact Details+

Contact Company:Bharat Serums and Vaccines

Address:Airoli, Navi Mumbai.

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Disclaimer: Bharat Serums and Vaccines Limited (BSV) has a merit-based employee selection practice and it does not charge / accept any payment or security deposit from job seekers either during the selection process or while inviting candidates for an interview. Please do not respond to any unsolicited or fraudulent communication offering a job or an interview call from BSV against payment of money.