Affairs Director (EU)
Responsible to: VP, Global Regulatory Affairs
Responsible for: No
To assist with development and execution of regulatory
strategies for Cell Medica products.
To ensure that regulatory submissions in the EU and other
designated territories, are granted and maintained in support of the Company’s
To coordinate regulatory meetings and communications with
European competent authorities.
with development of regulatory strategies for new products.
co-ordinating role to prepare for, attend and provide regulatory expertise at
regulatory authority meetings
and submit CTAs, orphan drug designations and MAAs to meet company goals and
• Review all
regulatory agency compliance materials to guarantee accuracy, timeliness,
comprehensiveness, and adherence to regulatory standards.
current knowledge of relevant EU regulations including proposed and final
• Act as a
company expert in EU Regulatory Affairs, providing updates, support and
education as required
• Provide EU
regulatory guidance to departments or development project teams regarding
design, development, evaluation, or marketing of products.
with external collaborators and manage external resources e.g. CROs
to the establishment of the global regulatory function and organisation of
company regulatory data
• Play an
instrumental role in the global regulatory affairs function through active
participation and collaboration
Education and Experience
• 5 to 7
years’ equivalent experience in EU Regulatory Affairs including significant
industry experience (experience in territories outside the EU e.g Asia, US
qualification – minimum Bachelors Degree (post graduate qualification preferred)
in immunology, cell/gene therapy or oncology advantageous
experience with new product development for biotechnology products.
success in gaining regulatory approvals through meticulous preparation, timely submissions
and expert regulatory input at regulatory authority meetings
understanding of EMA and national European regulation
of external resources and liaison with external collaborators
motivated and able to work independently
• Ability to
think creatively in order to achieve solutions to potential regulatory
communicator with ability to interact successfully across disciplines and
credible and authoritative