Executive To Assistant Manager - IRA (ROW Market)

Roles and Responsibilities:

• Compilation and review of dossiers as per requirements for ROW Market.
• Review of Technical Documents (EDMF, Product Development Report, BMR, BPR, Analytical Method Validation Report, Specification-STP, Stability Report, BE Study Report etc.)
• Compilation and review of dossiers as per requirements for different Countries.
• Compilation of deficiency responses of new product submission and Backlog dossier to submit to DI consultancy.
• To review the proposal for any post-approval changes as per the current regulatory guidance.
• To prepare and submit the variation for post approval changes.
• To communicate and follow up with overseas regulatory team /agent/ distributors to ensure timely filing of new submission or variation.
• To review various artworks & comments for ongoing commercial supply & products for the new launch.
• To prepare and maintain various registration Data base & updating at Central Depository
• To provide NPIF for various products for Market requirements to packing department for preparation of change part and Artworks.
• Compilation and Review of commercial and supporting documents (1.e. Commitments, File Note, SFG-FG Linkage, FSC, LIFs, etc.)
• To coordinate with GDSO & vendor to get DME, GMP certificate etc. for filing purp

Desired Candidate Profile

• Should have similar experience of International Regulatory Affairs.
• Should have good communication and interpersonal skills
• Should have good excellent practical knowledge of regulatory submission in ROW Market.