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