Regulatory affairs

Looking for a dedicated and experienced professional to join our Regulatory Affairs team.

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.

Knowledge about the various types of applications filed on the Online ODLS portal forTelangana and ONDLS portal.

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. 

Scale-up & Exhibit Batches, Tech Transfer (IR/SR/ER), Documentation, Troubleshooting & AN DA Evaluation

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

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

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

B.Pharm / M.Pharm with Communication skills, documentation expertise & problem-solving ability. Regulatory Affairs at Titan Labs