Biological E. Ltd Recruitment -Send Resume To HR Mail

Biological E. Limited (BE), the first private sector biological products company in India and the first pharmaceuticals company in South India was established in 1953. Originally incorporated as Biological Products Private Limited, and launched by Dr. Vijay Kumar Datla, today, BE is a globally recognised vaccine manufacturer and has supplied over 2 Billion Doses of Vaccines till date all over the world.

• Important Details :
• Location: India
• Post of date:29/11/2024
• Selection Process: The selection will be on the basis of Interview.
• Mode of Interview: Face to face
• Interview Rounds of Interview: HR

Job Description –: Greeting from Biological E. Ltd!!!!

Vacancy details:

• Job vacancy for Deputy Manager – Regulatory Affairs, Vaccine Products for India, WHO & RoW markets.
• Qlfn : B. Pharmacy/M. Pharmacy/ M.Sc. with 7 to 11 years

Main purpose of the Job:

Responsible for compilation & submission of dossiers and other technical information for various approval related to NRA & WHO.

Job responsibilities :

Preparation and Review of Regulatory Submission Packages related to Indian NRA such as Post Approval Change & Marketing Authorization Applications

Assisting in Responding Queries for various regulatory authorities.

Preparation of dossiers / submission packages for NRA submissions.

Preparation of dossiers for registration in ROW countries.

Up to date maintenance of Documentation database available with RA.

Coordination with cross-functional departments like QA, QC, Production, Warehouse, Distribution and Marketing.

Product Lifecycle management.

Routine Interaction with QA-documentation for updating master files.

Review of Pack Profiles.

Review of Artworks (Labels and Package Insert).

Preparation / compilation of technical documents related to tenders / queries.

Arranging Samples required for registration.

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.

Approvals from RCGM/ GEAC for recombinant Products.

Any other tasks assigned by the supervisor.

Candidate desired skills :

Hands on experience in Biological Products registrations / Marketing Authorization approvals from various regulatory authorities.

Interested candidates can share their resume’ to : vinod.gopishetty@biologicale.com with CC to : careers@biologicale.com