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