Bharat Serums and Vaccines Limited is a leading biopharma company focusing on women’s health, fertility, critical care and emergency medicine. We are a Mankind Pharma Limited Group Company. Mankind Pharma is ranked among the top 3 pharma companies in India. Mankind Pharma has a base multi-speciality therapy business, consumer healthcare business and speciality business, BSV is the super speciality business run as an independent group company. BSV’s focused therapy areas such as women’s health & fertility, for example, makes us one of the only few biopharma companies that manufacturers complex and niche biosimilars, making us a super speciality business.

About the Role:
Preparation and reviewing of CTD and ACTD dossier.
Co-ordination with Plant and R&D; to collect inputs required for Regulatory Submission.
Co-ordination with plant for Regulatory compliances.
Timely achievement of monthly plan & timely query response.




Gap Analysis/Updation of Master data.
Review of Change Controls, Stability Protocol, Clinical Trial Protocols & Artworks.
Get feedback from all the countries for respective variation, and their timely submission and renewals.
Master data Updating.
Follow ups with plant for documentation regularly and review meeting.
Tracking and reviewing of document requirements of upcoming current filing in ROW and Emerging markets.

Qualifications:
M.Pharma/MSc.Biotech with 6 to 8 years of experience.

Required Skills:
eCTD
CTD
Validation
ICH requirements
USFDA Filings
WHO Prequalification
MCC South Africa for Biological and Biotech products

Preferred Skills:
Planning
Analytical thinking
People Management
Communication
Team Leading

📌 Manager- Regulatory Affairs-International(Biologics) (Mumbai)
🏢 Bharat Serums and Vaccines
📍 Mumbai