Regulatory Affairs - Sr. Executive | Vaccine/Biotech Industry

Desired Experience : 3-7 years

Job Location : Genome Valley, Shameerpet, Hyderabad

Preferred Industry : Vaccines / Biotech

Main purpose of the Job:

Responsible for Preparation of Regulatory Documents for submission to Indian NRA, WHO and other Regulatory Authorities.

Job Responsibilities:

1. Preparation of following Regulatory Submission Packages related to NRA submissions but not limited to.

a. Application for Post Approval Change(s)

b. Marketing Authorization Applications

c. Clinical trial applications

d. Support the submission of Import licenses/ export NoC

e. Support the preparation, review and submission of applications/ response to RCGM vide IBSC

f. Support in handling of SUGAM, IBKP, NSWS & ONDLS/ ODLS sites

2. Assisting in Responding Queries to various regulatory authorities.

3. Preparation of dossiers / submission packages for NRA submissions.

4. Preparation of dossiers for registration in ROW countries.

5. Maintenance of Documentation Data base available with RA.

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

7. Routine Interaction with QA-documentation for updating Master Files.

8. Review of Pack Profiles.

9. Review of Artworks (Labels and Package Insert).

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

11. Arranging Samples required for registration.

12. Any other support required by the other members of RA.

Interested Candidates having relevant experience can send in their CVs to HR.Intern4@biologicale.com by mention the subject as Applying for Department Name