Amol Bharadi
Regulatory Affairs professional with 7 years experience
Pune,Maharashtra,India | Pharma / Biotech / Life Science
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- Working in Regulatory Affairs Department for Global Market (US, EU, AU) and have 7 years of experience.
- Compilation of dossier & ensuring timely submission (eCTD) of dossiers for regulatory agencies.
- Preparation of responses for CMC deficiencies received from respective regulatory agencies.
- Preparation of post approval supplements package (variations & renewals) and handling complete product life cycle management for drug products.
- Review of dossiers, variation package prepared by colleague
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