Pulse Pharma job vacancy for Regulatory affairs department
We are Hiring
“An innovation driven Pharmaceutical company A strong marketing oriented & patient centric organization”
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: [email protected]
