Bharat Serums and Vaccines Recruitment 2023.Bharat Serums and Vaccines Notification full details below..Intrested and eligible Apply Online.Bharat Serums and Vaccines, we work in close partnership with our customers and the stakeholders to make a sustainable impact. We use science to advance industries.
- Post Name: Assistant manager- Regulatory Affairs
- Qualification: MS/M.Sc(Science) in Biotechnology,M.Pharma in Any Specialization
- Experienced: 6-10 year(s) of experience
Job Description: Greeting from Bharat Serums and Vaccines !!!
Important Details :
- Location: Navi Mumbai
- Post of date:22/05/2023
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face to face
- Interview Rounds of Interview: HR
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.
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.