ICON Clinical Research

Director, Regulatory Affairs

05 Jan 2021
04 Feb 2021
Regulatory Affairs
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Director Regulatory Affairs

Location: Flexible remote working, based in EU or at one of Global Office locations.

ICON plc, a leading Clinical Research Organisation, our mission is to help our clients to accelerate the development of drugs and devices that save lives and improve the quality of life!

We are looking for passionate, resilient, and inspiring individuals to join our Strategic Regulatory Affairs (SRS) team. SRS are a global team of regulatory strategists from pharma, CRO and agency backgrounds, with expertise in drug development, regulatory strategy and operational implementation, CMC and quality assurance. We deliver global strategic regulatory consulting, dossier management services and GMP Quality services

In this role, you will be responsible for regulatory strategy for a combination of current and prospective clients in Europe and Internationally (ex North America) for drugs and biologics. As a senior member of the SRS team, you will further be responsible for the strategic approach and client interactions necessary to securing new and repeat business, facilitating issue resolution and ensuring project/program timelines/budgets are met. You will also maintain client relationships in the support of future business as the position participates in business development activities.

Responsibilities and accountabilities:
  • 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

  • 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

  • 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.

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