Executive To Assistant Manager - IRA (ROW Market)

Job Description

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.