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

We are looking for a passionate, resilient, and inspiring individual to join our team. As a Director, Regulatory Affairs, you will contribute to drug development, as part of the Strategic Regulatory Services (SRS) Regulatory Affairs team primarily through provision of regulatory guidance and operational support to early drug development, agency interactions, clinical trial applications and other tasks as required. We require an individual expert in the new EU Clinical Trial Regulation (CTR), capable of interpreting and operationalizing new guidance and supporting the SRS Team and other functional areas. In particular, an individual who can represent regulatory affairs and lead us through the transition of our clinical trials from CTD to CTR in collaboration with other functional areas. Experience with Cell and Gene Therapy is beneficial.

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
• Apply scientific principles and maximize compliance to all aspects of regulatory activities undertaking
• 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
• Development and implementation of strategies and regulatory submissions for PIP, OD, SME, Medical Device applications, post-licensing activities as applicable
• 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 efficiency and quality of insight
• Anticipate key project risks. Proactively develops and executes mitigating strategies effectively as required
  
  

OPERATIONAL

• If a People Leader, be responsible for human resource management activities including maintenance of proper staffing levels, resource optimization, attainment of individual and team goals, employee relations, mentoring, talent/career development, and rewards/recognition based on achievement of goals
• Delegate and ensure completion of special assignments (e.g. job descriptions, handbook updates, SOP scientific consulting)
• Comply with all relevant SOPs, work programming, time-keeping, iLearns, policies and procedures
  
  

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 fulfil 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.