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Job Title:Regulatory
Affairs Director (EU)

Responsible to: VP, Global Regulatory Affairs

Responsible for: No
direct reports

Role

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
business objectives.

To coordinate regulatory meetings and communications with
European competent authorities.

Responsibilities

• Involved
with development of regulatory strategies for new products.

• Undertake
co-ordinating role to prepare for, attend and provide regulatory expertise at
regulatory authority meetings

• Prepare
and submit CTAs, orphan drug designations and MAAs to meet company goals and
timelines

• Review all
regulatory agency compliance materials to guarantee accuracy, timeliness,
comprehensiveness, and adherence to regulatory standards.

• Maintain
current knowledge of relevant EU regulations including proposed and final
rules.

• 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.

• Liaise
with external collaborators and manage external resources e.g. CROs

• Contribute
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
desirable)

• Scientific
qualification – minimum Bachelors Degree (post graduate qualification preferred)

• Experience
in immunology, cell/gene therapy or oncology advantageous

• Regulatory
experience with new product development for biotechnology products.

• Demonstrable
success in gaining regulatory approvals through meticulous preparation, timely submissions
and expert regulatory input at regulatory authority meetings

• Thorough
understanding of EMA and national European regulation

• Management
of external resources and liaison with external collaborators

Personal Attributes

• Self
motivated and able to work independently

• Ability to
think creatively in order to achieve solutions to potential regulatory
roadblocks

• Good
communicator with ability to interact successfully across disciplines and
levels

• Professionally
credible and authoritative


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