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.
Interested candidates can share your profile to : firstname.lastname@example.org
Last date : 20th September 2023