Ganesh Hole
Data Analyst | MBA-Operation and Supply chain management | Pharma and Health care Management | Bachelor of Pharmacy
- Role
- Regulatory Affairs Officer at Gennova Biopharmaceuticals
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Ganesh Hole
Regulatory Affairs professional with 4+ years of experience in pharmaceutical regulatory…
Experience
Regulatory Affairs Officer
Dec 2024 — Present · Pune, IN
Collaborated with cross-functional teams, including Production, Quality Control, Quality Assurance, and R&D to collect and analyze the requiredinformation for regulatory submissions and compliance.Reveiwed and compiled detailed quality dossiers in strict alignment with regulatory standards for the African and Asean markets, ensuringadherence to the latest submission formats, including country specific format, CTD and ACTD while meeting specific country regulations andguidelines.Reviewed technical documentation for product registration, including PDR, BMR, Process Validation, Analytical Method Validation, and StabilityStudy Reports, ensuring regulatory compliance.Reviewed labeling information, including package inserts, SMPC, and PIL, ensuring compliance with country-specific guidelines.Compiled and organized administrative documentation in Module 1, such as COPP, manufacturing licenses, and GMP certifications ensuring fullregulatory compliance with country-specific guidelines and requirements.Knowledge about Post Approval Changes, PSUR and Post Marketing Data.Comprehensive expertise in compiling Modules 4 and 5 for biosimilars, ensuring regulatory compliance and presenting robust data to supportsafety, efficacy, quality, pharmacodynamics, pharmacokinetics, and preclinical data.Handled query responses for regulatory submissions across multiple countries.
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.