OVERVIEW
FOCUS AREAS
25 years of global life science expertise across pharma, CROs, and regulatory agencies in ICH, LATAM, MENA
Regulatory Affairs for Biologics, Biosimilars, and Vaccines
Regulatory Strategy (EU, LATAM, MENA, Asia)
Global CMC Strategy and Execution
Due Diligence Projects Worldwide
Regulatory Intelligence and Policy Development
International market expansion
Regulatory Submissions and Post-Approval Changes
Leadership in Regulatory Team Development and Training
Ifty Saiyed is a highly accomplished Global Regulatory Affairs leader with over 25 years of experience across multinational pharmaceutical companies, contract research organisations (CROs), and international regulatory agencies. His expertise spans a wide array of regions, including ICH markets, LATAM, and MENA, where he has consistently demonstrated the ability to navigate complex regulatory landscapes and provide strategic guidance on diverse, high-impact global projects.
Recognised for his strategic acumen, Ifty specialises in addressing complex regulatory challenges, particularly in the context of market expansion. He has a proven track record of building and mentoring high-performing teams, fostering seamless collaboration across multidisciplinary project teams, and cultivating strong relationships with external stakeholders and regulatory bodies.
Ifty’s strengths extend to technical writing, regulatory submissions, and conducting global due diligence assessments, ensuring that projects are executed with precision and aligned with regulatory expectations. He is deeply engaged with regulatory intelligence and policy, continuously evolving strategies to anticipate global regulatory trends and requirements.
Incorporating his knowledge of emerging technologies, including artificial intelligence, Ifty applies a forward-thinking approach that equips organizations to confidently navigate the dynamic regulatory landscape with innovation, compliance, and strategic foresight.
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EDUCATION:
BSc (Hons) in (Pharmaceutical Sciences)
De Montfort University, Leicester – School of Pharmacy
Dissertation: “Requirements for Medical Device Registrations in the Pacific Rim”CERTIFICATIONS:
Executive Certificate – MIT Sloan School of Management
Massachusetts Institute of Technology (MIT), Cambridge, MA
Developed advanced leadership capabilities to drive strategic management practices and organizational objectives for senior executives.
Key areas of focus included leadership strategy, negotiation, innovation, and managing technical professionals and complex organisations. -
LEADERSHIP POSITIONS:
Executive Certificate – MIT Sloan School of Management
- Massachusetts Institute of Technology (MIT), Cambridge, MA
- Developed advanced leadership capabilities to drive strategic management practices and organizational objectives for senior executives.
- Key areas of focus included leadership strategy, negotiation, innovation, and managing technical professionals and complex organisations.
Senior Global Regulatory Affairs Advisor
- Extensive expertise across diverse regulatory landscapes, including the US, EU, Japan, Asia-Pacific, Latin America, and the Middle East.
- Delivered strategic regulatory guidance on product development, submissions, and market expansion, ensuring compliance with regional and global requirements.
Head of UK/IRL Regulatory Affairs, Lundbeck Ltd
- Directed all regulatory activities across the UK and Ireland, including licensing, submissions, and compliance.
- Served as the Responsible Person (RP) for manufacturing and distribution operations, ensuring adherence to Good
- Distribution Practice (GDP) and Good Manufacturing Practice (GMP) standards.
Team Leader, Ashbourne Pharmaceuticals
- Led a regulatory affairs team focused on product lifecycle management, including maintenance, renewals, and variations of licensed products.
- Developed and executed regulatory strategies to support the continued availability and compliance of marketed products across multiple jurisdictions.
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