Responsible for developing and implementing UK regulatory strategies for product(s).
Lead the UK RA team to manage regulatory aspects of compounds.
Collaborate with key internal stakeholders on UK MAA strategy.
Manage the content and prepare regulatory (UK MAA) dossiers.
Oversee communications, submissions, and approvals from regulatory agencies.
Act as the RA liaison within the UK Leadership team and provide input into UK business strategy.
Anticipate and mitigate regulatory risks while maintaining knowledge of regulatory intelligence.
Mentoring junior team members and representing BeOne at UK industrial meetings.

Bachelor’s degree required; advanced degree preferred.
Minimum of 8 years’ experience in the biotechnical or pharmaceutical industry.
Minimum of 8 years’ experience in a Regulatory capacity.
Experience working with MHRA regulatory procedures is mandatory.
Sound understanding of the drug development process and UK regulatory requirements.
Recent experience with oncology products and MAAs, ODD, PIP is preferred.

Associate Director, Regulatory Affairs

Key skills