Paramjeet Singh
Drug regulatory affairs at Cencora Pharmalex Private Ltd.
- Role
- Assistant Manager at PharmaLex
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
Experience
Assistant Manager
Feb 2024 — Present · Noida, IN
Responsible for the preparation and reviewing of CMC ( Chemistry, Manufacturing and Controls) for submission to regulatory authority for Global Market (include US, EU and International market).Responsible for the Life cycle management/Post-Approval of product (Variations Annual updates and Renewals) for Global Market (include US, EU and International market). Lead the preparation and submission of annual reports, facility registrations, facility renewals, and product renewals for global markets.Collaborate with authors, reviewers, and subject matter experts to ensure timely delivery of high-quality CMC documents required for regulatory submissionsInitiated and managed CMC product timelines to ensure the timely achievement of regulatory milestones and strict adherence to submission schedules. Responsible for execution and Review of complete CMC part. Entertaining all regulatory queries and ensure timely resolution with regulatory bodies. Actively participate in cross-functional special project teams, including involvement in the Nitrosamine team, contributing regulatory expertise to support project objectivesSupport towards the preparation of proposals on regulatory strategy for clients and presently working with Bayer AG Germany
Education
Kendriya Vidyalaya DLW varanasi
Intermediate
SRMS College of Engg. & Tech, Bareilly
Bachelor of Pharmacy - BPharm, B. pharma
2009 — 2013
Rajiv Gandhi University of Health Sciences, Bangalore
Master of pharmacy, Medicinal and Pharmaceutical Chemistry
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