Director, Regulatory Affairs

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

**Director, Regulatory Affairs**

As Director, Regulatory Affairs you are expected to:

- Recognize the importance of, and create a culture of, process improvement with a focus on streamlining our processes, adding value to our business and meeting client needs.
- Demonstrate and actively promote an open and honest working environment to encourage close teamwork and foster knowledge transfer
- Travel (up to 25% dependent upon business needs) domestic and/or international
- Proactively communicates objectives and results with clients, leadership team and all functional partners
- Undertake all required tasks requested to meet departmental and project goals and manage and lead various departmental initiatives as required.
- Identify department process and procedure improvements and assist in implementation of continuous improvement measures to ensure department expertise and to meet department's goals
- Identify issues, proactively seek advice and address them in a timely manner, including development of preventative actions
- Champion review/update of existing department standard operating procedures
- Represent ICON Regulatory Affairs at conferences, committees, webinars and other suitable opportunities
- Provide support to more junior team members on complex projects
- Performs other duties and tasks as are allocated at the reasonable discretion of the Company

SUBJECT MATTER EXPERTISE
- Contribute as EU CTR Subject Matter Expert (SME) and support transition of trials from CTD to CTR
- Contribute as cell and gene therapy SME
- Participate in regulatory and/or clinical trial project teams as required
- Prepare/oversee/review/write core regulatory submissions to support CTA, IND, MAA, NDA or equivalents
- Oversee preparation and review of scientific and regulatory documents and communication to Regulatory Authorities, in collaboration with internal and external functional experts
- In collaborations with functional experts, advise on regulatory aspects of protocols and clinical trials
- Function as primary liaison with regulatory agencies for designated projects and designated clients.
- Lead and take oversight on the regulatory intelligence function.
- Oversee and lead regulatory input for regulatory agency meetings.
- Perform high-level review and sign-off authorisation 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 and to our clients.

CLIENT DEVELOPMENT
- Contribute as client Partnership Lead
- Conceptualize and draft, or lead, a complete proposal based on a client idea or RFP.
- Be aware of project contracts and terms, be able to review them critically and initiate change orders when needed. Manage the financial control of projects (from contract state to invoicing) and be involved in financial processes within the department.
- 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 and deal flow
- Key account lead for a combination of current and prospective clients
- Independently develop project plans and scientific content in proposals and achieve good conversion rate of submitted and won proposals
- Represent Service Line at internal and external meetings and strategy review presentations/overviews
- Maintain positive client contact, serve as escalation path for unresolved issues as necessary, and initiates client dialogue and updates on project progress
- Regularly contributes to industry thought leadership.

PROJECT & RISK MANAGEMENT
- Take ownership of final budget, deliverable and project timeline and deliver work on time, in a profitable manner
- Efficiently balance resourcing and financial results to meet the clients needs and departmental goals, including outsourcing strategies
- Organize and monitors workloads in line with budget and time to ensure project effici