Srinivasa Rao – Background:
- Accomplished Regulatory Affairs Leader with over 25 years of experience in the pharmaceutical industry.
- Skilled in driving global regulatory strategy, ensuring compliance, and achieving strategic objectives.
- Proven track record of securing approvals and leading successful product launches.
- Exceptional communicator and team leader dedicated to excellence.
Areas of Expertise:
- Global Regulatory Strategy
- Product Development
- Regulatory Compliance
- Team Leadership
- Strategic Planning
- Cross-Functional Collaboration
- Innovation and Problem-Solving
Professional Experience:
Owner and Pharmaceutical Regulatory Consultant
- US PharmaReg LLC | 2024 – Present
- Provide specialized consulting services in global regulatory compliance and product development for pharmaceutical companies.
Vice president, Regulatory Affairs
- Nephron Pharmaceuticals Corporation | 2021 – 2024
- Directed regulatory strategy and operations, ensuring compliance and successful submissions for pharmaceutical products.
Vice President & Head of Regulatory Affairs, North America
- Dr. Reddy’s Laboratories | 2013 – 2021
- Managed regional regulatory affairs strategy, leading teams and driving successful product launches in North America.
Senior Director, Regulatory Affairs
- Pfizer Inc. | 2010 – 2013
- Implemented regulatory strategy and managed compliance activities for a portfolio of pharmaceutical products.
Director, Regulatory Affairs
- Sandoz Inc., (a Novartis company) | 2007 – 2010
- Managed regional regulatory affairs strategy, leading teams and driving successful product launches in North America.
Director, Regulatory Affairs (Held various titles)
- Taro Pharmaceuticals Inc. | 1997 – Oct 2007
- Oversaw regulatory submissions and ensured timely execution of projects for pharmaceutical products.
Career highlights:
- Filed and received approvals on NDAs, IND, ANDA, 510K and DMF submissions, facilitating product launches and ensuring regulatory compliance.
- Managed Global Markets, securing competitive approvals for US Market and leading successful launches of First-to-Market ANDA products.
- Received United States Patents for innovative pharmaceutical compositions, demonstrating expertise in product development.
Education:
- Doctor of Pharmacy (PharmD) – Shenandoah University
- Master of Science (MS) in Industrial Pharmacy – Long Island University
- Master of Science (MS) in Pharmacy – Birla Institute of Technology and Sciences
- Bachelor of Pharmacy (B. Pharm) – Annamalai University
Additional skills:
- Licensed Pharmacist (NY & NJ)
- Strong Leadership and Team Building
- Excellent Communication and Interpersonal Skills
- Strategic Thinking and Problem-Solving Abilities
