Director Regulatory Affairs

Location: Dublin, Ireland or London, UK (will also consider flexible remote based in EU)

ICON plc, a leading Clinical Research Organisation, employing 14,500 people across 97 offices in 38 countries - 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. As the Director Regulatory Affairs International, you will be responsible for the oversight of the Strategic Regulatory Services (SRS) International Regulatory team who focus on provision of strategic consulting activities outside of USA and Canada and for growth and development of the team through business development activities.

In this role you will lead the team and also lead regulatory strategy for some clients to support registration (new and maintenance) in Europe and Internationally for drugs and biologics, and be responsible for the strategic approach to securing new business, facilitating issue resolution, 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:

• Manage and oversee the SRS International Regulatory team
• Serve as a resource for SRS team members and ICON colleagues, providing advice on project and Regulatory strategies
• Actively anticipate and develop initial or alternative regulatory strategies, consulting with other resources within the organisation as required. Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise
• Responsible for managing team workflow including prioritising project objectives, and establishing timeframes for projects with clients. Responsible for overseeing progress and completion of projects with project team members, ensuring timeframes and deadlines are met
• Effectively prioritise and complete multiple projects within established timeframes and within budget
• Train, coach, and develop assigned individuals to build team expertise
• Enthusiastically monitor for new regulatory requirements and share key findings
• Lead preparation of quotations for potential projects that may cross multiple service areas within the company
• Manage assigned projects within budget, preparing change orders as needed
• Provide thought leadership, speak at conferences and webinars, as appropriate

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 to motivate staff to seek creative solutions to issues surrounding timely, on-budget, and quality delivery. Focuses on resolving problems and makes decisions in a timely manner
• Ability to develop and maintain excellent rapport with clients
• Highly motivated and proactive
• Through knowledge of budgetary and financial management (budget, development, time and cost, forecasting, revenue, margin, profit and loss, invoicing, etc.)
• Knowledge of business development process
• Shown ability to understand and communicate corporate policies and procedures
• 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
• Problem solving skills balanced with an awareness of business objectives. Good judgement in the face of difficult and clear situations
• Planning and organisation: Plans work effectively to meet goals and ensure timely completion of assignments. Manages time effectively. Has a routine or system for completing work
• Attention to detail: Identifies and resolves discrepancies across various source documents, including published and unpublished documents. Notes and resolves errors in written documentation
• Proficiency in all MS-Office applications, including Word, Excel, Powerpoint

Education/Experience

• Bachelor's degree in a relevant discipline, preferably in a 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 Regulatory Affairs
• Experience supporting business development activities and people management.
• Experience presenting at applicable industry conferences and/or publications in regulatory affairs.