Director, Regulatory Affairs

Actively anticipate, develop and implement initial or alternative regulatory strategies for contracted clients.

Act as scientific thought leader for ICON. Support initiatives to ensure ICON is at the leading edge of new regulatory developments e.g. DCT, COVID-19, GMO, ATMP development, Cell and Gene therapy etc.

Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise, consulting with other resources within the organisation as required.

Manage workflow including prioritising project objectives, and establishing timeframes for projects with clients and managing client contracts.

Effectively prioritise and complete multiple projects within established timeframes and within budget

Train, coach, and develop assigned individuals to build overall team expertise

Develop and implement strategies and regulatory submissions for PIP, OD, SME, MAA and post-licensing activities as applicable.

Function as primary liaison with regulatory agencies for designated projects and designated clients

Conceptualize and draft complete proposals based on a client idea or (Request for Proposal (RFP) including Independent development of project plans and scientific content for clients. Achieve a good conversion rate of submitted to won proposals.

Act as scientific thought partner with the client and the project team throughout the project.

Initiate and nurture client relationships and maintain contacts to build reputation.

Speak at conferences and webinars, as appropriate.

May lead a team

Knowledge/Skills/Attributes

Thorough working knowledge of local and global Health Authority regulations, guidelines, policies, GCP and GxP, ICH Guidelines

Effective project management skills

Ability to make decisions independently and operate autonomously

Sound listening, conflict management, and negotiating skills

Excellent planning, organisation, interpersonal, time, and change management skills

Demonstrable good problem solving, judgement, and decision-making skills

Ability to develop and maintain excellent rapport with clients

Knowledge of business development process

Excellent verbal and written communication: Conveys thoughts in a clear, concise, and accurate manner. Uses appropriate regulatory, medical, and scientific nomenclature. Listens carefully and asks questions when necessary to ensure understanding

Planning and organisation: Plans work effectively to meet goals and ensure timely completion of assignments. Manages time effectively.

Attention to detail: Identifies and resolves discrepancies across various source documents, including published and unpublished documents. Notes and resolves errors in written documentation

Experience in client interaction and/or in a consulting environment is advantageous

Education/Experience:

Bachelor's degree in a relevant discipline, preferably in life sciences, or other healthcare field.

Advanced degree (MSc., PhD., M.D., Pharm.D, MBA) in the biological, medical, chemical or engineering field may be beneficial.

Minimum of 12-15 years related experience in Regulatory Affairs setting, in Pharma or CRO, with emphasis on EU and International (Ex North America) Regulatory Affairs

Experience supporting client development activities and people management.