Abhay K.
Speaker || Motivator|| Influencer|| Team leader|| Collaborator\\nEx Glenmark | Ex Lupin| Ex Ipca\\nRegulatory Affairs Professional
- Role
- Regulatory Affairs Manager at Intas Pharmaceuticals
- Location
- Mumbai, IN
- LinkedIn followers
- 500 followers
About Abhay K.
Contributed successfully for scaling up the international business to multifold by achieving site and product registrations in Emerging Markets
Experience
Regulatory Affairs Manager
Sep 2018 — Present · Ahmedabad, IN
Intas Pharmaceuticals Ltd- Plasma Fractionation Centre.• Responsible for medical affairs, regulatory affairs, clinical development projects, strategic inputs etc. Responsible for maintaining marketing authorizations and for creating Regulatory Variation packages.• Review technical document and preparing CMC part of dossier for regulated market. Response preparation and variation submission to health authorities. Review and application of site GMP application for Global regulatory authorities.• Responsible for planning and submission of lifecycle management activity of marketing authorisation applications for emerging markets.• Managing the team via project management, prioritization, direction and leadership to team members in order to accomplish regulatory project deliverables within stipulated time lines.• Monitoring and reporting regulatory submissions activities• Participating in regulatory submission strategy development, applying expertise to influence strategies.
Education
Indian Institute of Management Tiruchirappalli
Certificate
2022 — 2022
Shri Neminath Jain Brahmacharyashrmas Trusts College of Pharmacy, Chandwad, Dist.Nashik 423101
Bachelor of Pharmacy (B.Pharm.)
2001 — 2004
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