DRA

This role is pivotal in managing activities pertaining to product lifecycle management, quality management and pharmacovigilance, including variations and renewals, SOP development, risk management, and trainings.

Regulatory Knowledge & Compliance, Communication & Coordination, Analytical & Problem-Solving Abilities.

Experience and expertise in authoring, compiling and submission of country specific submissions (MAA,BLA, and post approval changes) of Biologics/Biosimilar products in various markets- Regulated (EU/US/Canada) and emerging markets. 

Contributes to the development and implementation of regulatory strategy for assigned region as a member of the Global Regulatory Affairs functional team

Knowledge of regulatory affairs related to biotech research and commercialization. Regional Centre for Biotechnology

Expected M.Pharm by education with 3+ years experience for Document requisition and review, Dossier Preparation, CTD, ACTD, Country specific for ROW Market

M.Pharm, B.Pharm, M.Sc, B.Sc. Experience of QC documents, Specification and STP Preparation. Experience of method development, method validation and documentations

Prepare, compile, review, and submit product registration dossiers in CTD I eCTD format as per country-specific requirements and EAEU Unified Registration Procedure.

Evaluation of regulatory documents, compilation of dossier and submissions to CDSCO-HQ/CDSCO-Zonal offices for regulatory approval of drug substance and drug products.