Jaydeep Maradiya
Senior Manager at GSK
- Role
- Regulatory Senior Manager at GSK
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Jaydeep Maradiya
Experienced professional with demonstrated history of working in the Regulatory Affairs domain (CMC and Global labelling) with people and functional management abilities (KPIs, forecasting, resource mapping, recruitment, talent management, people development, coaching, business performance and compliance, transformation, simplification, automation). Skilled in project management, dossier preparation, submission, handling response to HA queries and post-approval activities. Well versed with patents/exclusivity, GMP, eCTD & core R&D functions.
Experience
Regulatory Senior Manager
Dec 2024 — Present · IN
Global labelling OperationsFunctional lead | Country labelling (Global/EU process)Team lead | Country labelling & Lablling Business performance and complianceGlobal labelling SME | Labelling transformation and transverse projectsReg Process Lead | to Labelling Global process owner for written standardsInvestigation Lead | Deviations and Issue MgmtCountry labelling SPOC and Inputter | ePIL, Translations automation, Automated Reg Intelligence, Automated Reg Info Mgmt, E2E Submission MgmtGRA assessment lead | EU excipient regulation update
Education
K. B. Institute of Pharmaceutical Education & Research
B Pharm, Pharmaceutical science
2004 — 2008
Indian Institute of Technology, Bombay
Summer research fellow, School of Bioscience and Bioengineering
2009 — 2009
RAPSOnline University
Regulatory Affairs Certificate Program, Pharmaceuticals
2020 — 2020
L.M. College Of Pharmacy
M. Pharm, Quality Assurance
2008 — 2010
Skills
- Regulatory Affairs
- Gmp
- Anda
- Generic Programming
- Pharmaceutical Research
- Regulatory Submissions
- Glp
- Medical Writing
- Pharmaceutical Industry
- Ectd
- Drug Delivery
- Abbreviated New Drug Application (Anda)
- Dissolution
- Pharmaceutics
- Drug Discovery
- Formulation
- Pharmacokinetics
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