Job for M.Pharm, B.Pharm, MSc in Regulatory Affairs at Pulse Pharma

Pulse is a fast-growing Pharmaceutical company with a vertically and diagonally integrated business model, focused on providing innovative product solutions to a large number of people around the world, to help them manage their health better & lead a quality life.

Post : Sr. Executive / Assistant Manager (Regulatory Affairs - EU Market)

Work Location : Corporate Office, Hi-tech City, Hyderabad.

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

Experience : 5 to 8 years of Regulatory experience in EU Market

Core Competencies :
• Compilation of DMF and Dossier for different Regulatory Agencies (USFDA, EDQM, ROW) in CTD/eCTD format based on the requirement.
• Preparation of amendments/updates/annual updates for the drug master files as per schedule.
• Issuing LOAs based on customer request and responsible for handling of the queries from the different Regulatory Agencies.
• Evaluation of change controls against to the current guidelines.
• Ensure on-going update for Dossier, customer queries, CCF tracker.