Biological E Ltd Job Opening For Msc/ M.Pharma/ B.Pharma - RA Dept

Biological E Ltd Job Opening For Msc/ M.Pharma/ B.Pharma - RA Dept 

1. Post Name: Regulatory Affairs
2. Education:B. Pharmacy/M. Pharmacy/MSc
3. Experienced:9-12 years      
4. Location:India
5. Salary: NA
6. Openings:NA

Note:If interested candidates can share your resume to mentioned mail ID Below.

Naveenkumar.linga@Biologicale.com

Job Description: Hiring For Regulatory Affairs in Biological E Limited! If interested candidates can share your resume to mentioned mail ID. Naveenkumar.linga@Biologicale.com

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