Associate Director of Regulatory Affairs - UK

In a newly created role, my client seeks an Associate Director who will provide local expertise for the UK& Ireland region, working as a member of the global Regulatory Affairs team to ensure implementation of best practices, and oversee their portfolio within the UK. This role operates across the full product life-cycle, offering varied work from new MAA, PIP and orphan submissions, new indications, to variations and labelling.

This position is particularly exciting, as it offers a high level of strategy, leadership and influence- the role holder will sit as part of the regulatory leadership team, engaging with other teams and driving advice on line expansions and strategic growth opportunities.

Role Responsibilities:

• Providing regional and local regulatory expertise- as the main contact with the MHRA you will ensure all MHRA requests and relevant new legislation are communicated internally
• You will obtain national regulatory intelligence through interaction with relevant authorities and participation with national industry organisations and committees
• You will be the local expert for regulatory queries coming from other functions, e.g. medical and supply chain, on topics such as compassionate use, exemption from local labelling and CTA requirements.
• You will submit and follow-up CTA applications and amendments, compassionate use programs and national requirements related to MAAs and subsequent variations

• You will have responsibility for reviewing and approving local promotional materials, publishing, and labelling including artwork and translations.
• It will be your responsibility to ensure the medical/promotional/institutional documents match the local requirements
• As well as the regulatory requirements, you will ensure all work is compliant with company policies and procedures, working with cross-functional teams on launch activities

Education and Experience Required

• Bachelor’s, M.Sc. or Ph.D. degree in life sciences
• Recognized as a knowledgeable resource for regulatory advice, across the full product life-cycle, with extensive relevant industry experience in regulatory affairs and understanding of current trends in local and regional requirements.

• Experience of managing complex negotiations with Regulatory Authorities and able to facilitate interactions with International Regulatory Affairs teams and other internal departments, as well as external parties.

Person Specification

• Driven to deliver within a highly innovative company, maintaining focus on transforming the lives of patients, their families and society.
• Strategic ability, as evidenced by an awareness of the issues facing the business overall and positioning of the local strategy relative to global and international requirements
• Self-motivated with a desire to take on new challenges, to help build an organization and still be part of a team taking a hands-on approach to projects.
• Exhibit ownership and accountability for all projects and internal assignments; plan, schedule and arrange own work activities with limited direction
• Good interpersonal skills and ability to deal effectively with a variety of personalities
• Strong analytical ability; and an ability to deal with ambiguity, uncertainty and complexity in a fast-paced environment
• Display solid ethics and fully comply with all regulatory, legal and industry codes of conduct.
• Fluent written and spoken English, with Excellent communication and presentation skills.

Local and international travel may be required, but this role will be based from London in line with many of the other collaborating functions. Flexible work from home will be the norm going forward, so about 50:50 home:office generally speaking.

Please apply today to be considered or contact Katie Dunbar on +44 (0)1293 584300 for more information.