BIOLOGICAL E. LTD - Hiring for Regulatory Affairs Department
Biological E. is Hiring!!
Department: Regulatory Affairs (Preferably Pharmaceutical Industry in Parenteral – Vaccines/Biologics would be an added advantage).
Experience: 9-12 years
Qualification: B. Pharmacy/M. Pharmacy/MSc
Ø Biological Products registrations / Marketing Authorization approvals from various regulatory authorities (ROW, WHO & NRA-India).
Ø Regulatory strategies development for New Drug approvals/ registrations & Post approval changes (PACs).
Ø Regulatory compliance for Biological products (whole cell & sub unit vaccines, recombinant vaccines, conjugate vaccines and viral vaccines (inactivated & live attenuated)).
Ø Product life cycle management.
Ø Guidance to cross functional teams on regulatory expectations for India, WHO and other ROW countries.
Ø Active role in providing suggestions/ recommendation on various regulatory guidance/ draft regulations (NRA & WHO) to encourage manufacturer responsive regulatory environment without compromising the regulatory compliance.
Ø Approvals from RCGM/ GEAC for recombinant Products.
Interested candidates with relevant experience may share profile at Naveenkumar.linga@Biologicale.com
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