Panacea Biotec BSc Biotech & Life Sciences Job – Apply Online
AM – Regulatory Affairs – Vaccine & Biologicals – Panacea Biotec
About the Company
Panacea Biotec is a research-based life sciences company that is involved in the research, manufacturing and marketing of high-quality, affordable pharmaceutical, vaccines and herbal products. We are committed towards disease prevention by introducing innovative vaccines to reduce child mortality. Our facilities are WHO Prequalified, US FDA approved and cGMP compliant. Our products are available across more than 145 countries including US, Germany, among other markets.
About the Job
Role Description
- Registration in domestic & ROW countries on vaccines and biological products.
- Review the CMC data for vaccines, anti-sera, biological/bio-technology products dossiers and submit dossier for registrations.
- Interact with QA, Production, Quality Control on technical matters and to ensure the statutory compliance in a timely manner.
- Follow up with vaccines, biological products manufacturers for required information, data so as to comply with the vaccines registration requirements.
- Preparing, compiling and reviewing the technical documents to support country-specific regulatory submissions in a format consistent with applicable guidelines.
- Handling the submission of regulatory applications through SUGAM PORTAL (CDSCO), WHO PQ portal and State FDA portals.
- Tracking the regulatory applications with the authorities.
- Addressing and resolving the regulatory queries pertaining to the submitted dossiers.
Qualifications
- Bachelor’s degree in Biotechnology, Pharmacy, Life Sciences or related disciplines
- 3 to 5 years of experience in regulatory affairs for vaccines and biologicals.
- Good knowledge of global regulatory frameworks, policies and procedures regarding regulatory requirements for vaccines and biologicals.
- Good knowledge of Indian regulatory requirements for vaccines and biologicals, and ability to communicate with India’s regulatory authorities.
Apply for this job opportunity at this link.
Keywords: Panacea Biotec, BSc Biotech, Life Sciences, job recruitment, AM – Regulatory Affairs, Vaccine, Biologicals, New Delhi, Delhi, India. Panacea Biotec BSc Biotech & Life Sciences Job – Apply Online. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook
