Megha Dani
Global Regulatory Affairs, Team Lead at Dr. Reddy\'s Laboratories
- Role
- Team Lead Global Regulatory Affairs at Dr. Reddy's Laboratories
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Megha Dani
With 20+ years of comprehensive leadership experience in the pharmaceutical industry, I bring a proven track record of driving generic drug product filings and approvals. I have strategically managed and delivered over 60 generic drug products, including complex generics, to achieve regulatory approvals and commercialization across diverse global markets (US, Canada & EU). My strengths include cultivating robust cross-functional and international team partnerships and fostering highly effective communication to navigate complex drug development and regulatory landscapes.
Experience
Team Lead Global Regulatory Affairs
Oct 2014 — Present · Hyderabad, IN
Lead and mentor a team of regulatory affairs professionals, with direct accountability for shaping and executing robust global regulatory strategies.• Oversee the development and submission of high-quality dossiers, ensuring compliance with US, European, and Canadian regulatory agencies\' expectations.• Accountable for collaborating with cross-functional teams to ensure expedited approval of generic drug products by effectively addressing agency comments and deficiencies.• Serving as the key Regulatory Affairs decision-maker in all stage-gate reviews throughout the product development and approval lifecycle.• Leading the development of a digital regulatory information management platform to streamline ANDA compilation, submission, and regulatory review.• Data analytics and management dashboards preparation related to regulatory submissions, deficiencies and approvals.
Education
Osmania University
Masters
Skills
- Regulatory Submissions
- Regulatory Requirements
- Anda
- Ectd
- Regulatory Affairs
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