Prashanth Narwade
Senior Manager Regulatory Affairs |Ex-Novo Nordisk | Ex-Roche | Ex-Eisai |
- Role
- Senior Manager Regulatory Affairs at AbbVie
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Prashanth Narwade
Proven track record in developing and executing risk-based Regulatory Strategies for…
Experience
Senior Manager Regulatory Affairs
May 2024 — Present · Bengaluru, IN
Overall Roles & Responsibilities: Operational Management: Lead end-to-end Robust Regulatory Strategies for New Product Registrations across Oncology, Immunology, Dermatology, Eye Care, and Aesthetics. Oversee NDA/sNDA, GCTs, and license-to-operate activities, including LCMs and PACs. Prepare and execute Health Authority meetings, ensure compliance through audits, and align regulatory strategy with R&D, Quality, and Supply Chain. Provide strategic insights on regulatory changes, competitive intelligence, and clinical trial data to support business decisions. People Management: Direct and develop a high-performing regulatory team through clear goal setting, coaching, and continuous upskilling. Lead resource planning, workload prioritization, and performance management. Drive individual development plans, talent and succession planning, and foster a collaborative, engaged team culture. Proactively resolve people- related challenges and contribute to organizational strategic planning. Functional Management: Drive Regulatory Affairs input to cross-functional forums including Global & Regional teams. Collaborate with Global stakeholders (R&D & Affiliates) & align with area VPs to shape Regulatory strategies. Manage budgets and guide the team towards strategic responsibilities. Contribute to therapy area leadership discussions, ensuring integration of Regulatory insights into broader functional direction.Highlights: Robust Regulatory Strategies and Risk mitigation strategies enabling faster execution of complex submissions. Spearheaded process simplification initiatives, significantly enhancing efficiency in regulatory submissions. Institutional Business: Ensure all the regulatory documents are in place to support Institutional business continuity Team Management: Guided the team on company systems, processes as well as regulatory requirements to help them navigate their assigned roles and responsibilities.
Education
Modern college of Pharmacy
Bachelors of Pharmacy
2005 — 2009
Arjan Khimji National Highschool
Higher secondary
2000 — 2002
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