Opportunity to work as Regulatory Affairs Assistant manager at Bharat Serums and Vaccines Limited

Bharat Serums and Vaccines Limited (BSV)  have made a significant contributions in the fields of biological, biotech, and pharmaceutical products. It’s commendable that our company is focused on influencing patient outcomes in the therapeutic areas of Women’s health and Critical Care, as well as IUI-IVF.

Job Title: Assistant Manager – Regulatory Affairs

Job Description: As an Assistant Manager in Regulatory Affairs, your primary responsibilities will involve the preparation, review, and coordination of regulatory documentation and submissions. You will collaborate with various departments within the organization, such as Plant and R&D, to gather the necessary inputs for regulatory submissions. Compliance with regulatory requirements and timely achievement of monthly plans will be crucial. Additionally, you will be responsible for conducting gap analyses, updating master data, reviewing change controls, stability protocols, clinical trial protocols, and artworks. It will be essential to obtain feedback from different countries for respective variations and ensure their timely submission. Other tasks include renewals, master data updating, regular follow-ups with the plant for documentation, and tracking and reviewing document requirements for new filings in ROW (Rest of World) and emerging markets.

Candidate Profile:

• Education: M.Pharma in Any Specialization, MS/M.Sc(Science) in Biotechnology.
• Knowledge: Proficient in eCTD, CTD, validation, ICH requirements, USFDA filings, WHO prequalification, and MCC South Africa regulations for biological and biotech products.
• Experience: 6 to 10 years of relevant experience in regulatory affairs.
• Additional Skills: Exposure to in-licensed dossier filing and out-licensing would be advantageous.

Additional Information:

• Experience: 6 to 10 years of experience in regulatory affairs.
• Qualification: M.Pharm
• Location: Navi Mumbai, Maharashtra.
• Industry Type: Pharma/Healthcare/Clinical research.
• Functional Area: Regulatory Affairs.
• End Date: 10th June 2023.
• For more articles, Kindly Click here.

  For pharmaceutical jobs, follow us on LinkedIn

  For more jobs, kindly visit our job section.

  www.pharmaceuticalcarrier.com/Jobs