Shreyas Prabhu
Regulatory affairs professional with expertise in regulatory strategy development/Life cycle management/compliance /project management /Early development/eCTD/RIM
- Role
- Associate Manager at Biocon
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Shreyas Prabhu
Results-focused and detail-oriented professional with 15 years of experience in Global…
Experience
Associate Manager
Sep 2022 — Present · Bengaluru, IN
Implemented CMC regulatory strategies for pharmaceutical products, preparing and reviewing CMC dossiers for commercial products. Managed end-to-end lifecycle of pharmaceutical submissions across various markets. Coordinate with cross-functional teams, clients, and global RA teams Conducted gap analysis and risk assessments of submitted documents, developing action plans. Authored CMC documentation for initial registration and lifecycle management, ensuring clarity and data support in scientific reviews. Published CMC documents in eCTD format for submissions to agencies such as CESP (Europe) and ESG (US and Canada). Handled the submissions and deficiency responses to China and Japan region Prepared annual reports/annual amendments and variation packages for relevant DMFs. Handled deficiency letters received from Regulatory Agencies, customers ensuring proper implementation of any changes in manufacturing or control processes. Contributed to new product development and maintenance of the existing portfolio from regulatory aspects Evaluated change controls, communicating any relevant changes in products or facilities to clients and Authorities, ensuring transparency and compliance. Provided all needed regulatory support, including opinion or advice to all other stakeholders.
Education
Sri Bhuvanendra College - Mangalore University
B.Sc Graduate
2004 — 2006
Kuvempu University
M.Sc
2006 — 2010
Global Institute of Regulatory Affairs
Post Graduation Diploma in Drug Regulatory Affairs
2012 — 2012
Skills
- Regulatory Affairs
- Glp
- Gmp
- Hplc
- Technology Transfer
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