Ph.D. degree in respective discipline, with a consistently good academic record throughout. Candidates who have submitted the thesis and awaiting award of degree may also apply.
To lead and manage all regulatory affairs activities at the manufacturing site located at Mumbai and LL locations, ensuring timely regulatory submissions, compliance with regulations, and providing strategic support to institutional and international business operations.
Job Description typically involves ensuring injectable pharmaceutical products meet safety and quality standards through testing, documentation, and compliance with regulatory guidelines like GMP.
This role provides regulatory leadership across the organization, ensuring compliance with FDA regulations and guidances, while driving continuous improvement in lifecycle management processes.
May enter data or assist in the creation of cases into the safety database in accordance with Sponsor, customer specific guidelines and Company standards if required.
B.Pharm with minimum 01 year of experience OR D. Pharm with minimum 03 years’ experience. Experience in Dispensary / Pharmacy of the Hospital having minimum 200 beds.