BACKGROUND
FOCUS AREAS
More than 10 Years working as a Regulatory Affairs professional within large and small pharmaceutical companies.
Life Cycle Management
Clinical Development
Product Launch
CMC
Michael is a seasoned Global regulatory professional with over a decade of experience with multinational pharmaceutical companies across both US and European markets. Most recently Mike has focused on radiopharmaceuticals applying his extensive knowledge to ensure compliance and successful product development.
Mike key strengths include effective collaboration with commercial teams in preparation for product launches as well as leading regulatory interaction with multidisciplinary project teams and with external regulatory bodies. Mike is recognised as an agile regulatory advisor, adept at navigating complex regulatory environments to achieve successful market entry.
Mike has extensive experience with radiopharmaceuticals, new product licence, especially compiling the module 1 and module 3 components.
He has been the regulatory representative on a number of cross functional development and brand teams providing strategic input to support successful regulatory submissions and product launches. He has expertise in label management including development, review and implementation
Mike is skilled in regulatory planning and execution with a track record of delivering high quality regulatory submission packages in a timely manner.
-
EDUCATION:
Master of Pharmacy, Welsh School of Pharmacy, Cardiff University
MPharm -
EXPERIENCE:
Overseeing Chemistry, Manufacturing and Controls (CMC) activities for regulatory submission.
Navigating global regulatory requirements to optimize submission timelines.
Providing strategic guidance on labelling development for market access and promotional activities.
Ready for Regulatory Clarity?
Stay informed as the regulatory landscape evolves. Subscribe to our blog to receive the latest updates on policy changes, FDA developments, and their impact on the life sciences industry.