Sr Dir, Regulatory Affairs

ICON plc is 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. We are seeking to expand our team and expertise, with the recruitment of a Sr Director of Regulatory Affairs to join our Strategic Regulatory Affairs (SRS) team.

As a Sr Director, Regulatory Affairs, you will provide strategic direction and management of the US Regulatory Team and contribute to the strategic direction and overall management of the Regulatory Affairs function as well as growth and development of the team through business development activities.

In this role you will lead the US team and also lead regulatory strategy for some clients to support NDA and BLA 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 leads US business development activities.

Responsibilities and accountabilities:

• Manage and oversee the US Regulatory team
• Provide effective strategic input into Regulatory Affairs activities on regulatory projects and/or clinical trials being undertaken by ICON
• If acting as Regulatory Project/Program Lead, responsible for managing each project and for monitoring and reporting progress and is accountable for all matters relating to that project and for communication with the client
• Represent the Regulatory Affairs Department in Business Development activities and generate new business opportunities.
• Instigate and lead high profile departmental improvement initiatives
• Apply scientific principles and maximize compliance to all aspects of regulatory activities undertaken
• Undertake all required tasks requested to meet departmental and project goals, as appropriate. Manage and lead various departmental initiatives
• Actively participate in and lead Regulatory Affairs Meetings
• Prepare and/or support proposals and bids and attend client and bid defense meetings; participate in Triage meetings as required
• Participate in clinical trial project teams and lead regulatory project teams as required.
• Initiate and oversee the planning and tracking of designated project activities including financial tracking
• Initiate product research and regulatory intelligence in support of designated regulatory activities, as required, and provide information on regulatory requirements
• Develop and implements local, regional and/or global regulatory strategies for regulatory projects
• Oversee preparation of, review, and/or author, scientific and regulatory documents and communication letters to Regulatory Authorities, in collaboration with Functional Experts.
• Oversee preparation of, review, and/or write, core regulatory documents for to investigational new Drugs (IND) and NDA/ BLA in collaboration with clients and internal Functional Experts. Advise on regulatory aspects of protocols and clinical trials as well as submission activities.
• Communicate/liaise with clients, regulatory agencies/competent authorities and/or other regulatory or Functional Experts on designated regulatory activities as required. Function as primary liaison with regulatory agencies for designated projects and designated clients
• Oversee regulatory input for regulatory agency meetings
• Perform high-level review and sign-off authorization of regulatory submissions as required
• Develop and maintain an in-depth current awareness of regulatory requirements through publications, seminars and appropriate training courses as deemed necessary.
• Advise senior management of key regulatory developments and their implications to ICON
• Liaise and work effectively with colleagues from other departments, clients, functional experts and Regulatory Authorities as required
• Provide thought leadership, speak at conferences and webinars, as appropriate
• Train, coach, and develop assigned individuals to build team expertise

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, organization, interpersonal, time, and change management skills.
• Demonstrable good problem solving, judgment, 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.
• Thorough 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 judgment in the face of difficult and clear situations.
• Planning and organization: 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 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.
• 15 - 20 years experience in Regulatory Affairs setting, in Pharma or CRO, with emphasis on US Regulatory Affairs
• Experience supporting business development activities and people management.
• Experience presenting at applicable industry conferences and/or publications in regulatory affairs

Benefits of Working in ICON:
Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfill your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.