Regulatory Affairs-Deputy/Assistant Manager/Senior Executive/Executive

Designation: Deputy Manager/ Assistant Manager/ Senior Executive/ Executive

Qualification: M. Pharmacy/ M. Sc/ B. Pharmacy

Experience: 3-11 years

Department: Regulatory Affairs - Vaccine Experience only

Location: Shameerpet

Role & 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.

Interested Candidates send in their CVs by mention subject as Applying for Department Name to "HR.Intern4@biologicale.com"