Biological E Limited recruitment 2021.Biological E Limited Notification full detailes below.Biological E limited is a privately held biopharmaceutical company based in Hotel Cygnett Lite, VIZAG., Telangana, India. It specialises in the areas of low-cost vaccine production.
Important Vacancy details:
- Post Name: Regulatory Affairs
- Education:B. Pharmacy/M. Pharmacy/MSc
- Experienced:9-12 years
- Location:India
- Salary: NA
- 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
Selection Process: The selection will be on the basis of Interview.
