Panacea Biotec BSc Pharma Job Recruitment – Apply Now!
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 pharmaceuticals, vaccines, and herbal products. The company is committed to disease prevention by introducing innovative vaccines to reduce child mortality. Panacea Biotec has WHO Prequalified, US FDA approved, and cGMP compliant facilities, and its products are available in over 145 countries, including the US, Germany, and other markets.
AM – Regulatory Affairs – Vaccine & Biologicals
Panacea Biotec · New Delhi, Delhi, India
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 the vaccines registration requirements.
- Preparing, compiling and reviewing the technical documents to support country-specific regulatory submissions in 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.
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Keywords: Panacea Biotec, BSc Pharma, Job Recruitment, Regulatory Affairs, Vaccine, Biologicals
