Fotis Baxevanis

Associate Director, Regulatory Affairs, International Cmc Eu Emea @MSD

London, GB

Line management and resolution of project issues through collaboration with the team and escalation to the CMC leadership team as appropriate.• Maximizing submission efficiency and quality to ensure a high rate of submission approvals by Health Authorities.• Development of CMC regional regulatory strategies for new marketing applications and post-approval changes. • Delivering of regional regulatory change control assessment, identifying regulatory requirements for CMC submissions for vaccine and small molecule products.• Preparation of documentation to support submission according to local/regional requirements in collaboration with subject matter experts in global CMC teams and local affiliates. • Representation of regional CMC on cross-functional teams to ensure mutual understanding of local/regional CMC requirements and program complexities, maintaining close communication with regional and local affiliates, regional Supply Chain teams and global CMC teams. • Support of product compliance by ensuring local registrations and lifecycle management and alignment with product manufacturing details. • Influencing CMC initiatives by internal and external engagement, including trade associations and regulators to pursue priority advocacy plans impacting the business.• Regulatory CMC SME in region, communicating proactively with global CMC teams on new regional registration requirements, new legislation, and guidelines.• Ensuring awareness of regional regulatory policy trends and maintenance of the regulatory intelligence repository for regional markets.

Anatolia College

High School

University of Bath

Doctor of Philosophy (Ph.D.), Biopharmaceutics

Aristotle University of Thessaloniki (AUTH)

MPharm, Pharmacy

University of Strathclyde

Master’s Degree, Pharmaceutical Analysis