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.
 

GENERAL
Recognizes, exemplifies and adheres to ICON's values which center on our commitment to People, Clients and Performance.
As a Director, Regulatory Affairs, the employee is 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
Demonstrates and actively promotes an open and honest working environment to encourage close teamwork and foster knowledge transfer

*Proactively communicates objectives and results with clients, leadership team and all functional partners
*Undertakes all required tasks requested to meet departmental and project goals and manage and lead various departmental initiatives as required.
*Represent ICON Regulatory Affairs at conferences, committees, webinars and other suitable opportunities
 *Performs other duties and tasks as are allocated at the reasonable discretion of the Company

SUBJECT MATTER EXPERTISE
*Applies 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
*Conceptualizes and drafts, or leads, 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.
*Acts as scientific thought partner with the client and the project team throughout the project
*Initiates and nurtures client relationships and maintains contacts to build reputation and deal flow
*Key account lead for a combination of current and prospective clients
*Independently develops project plans and scientific content in proposals and achieves good conversion rate of submitted and won proposals
*Represents Service Line at internal and external meetings and strategy review presentations/overviews
*Maintains positive client contact, serves 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
*Takes ownership of final budget, deliverable and project timeline and to deliver te work on time, in a profitable manner
*Efficiently balance resourcing and financial results to meet the clients needs and departmental goals, including outsourcing strategies
*Organizes and monitors workloads in line with budget and time to ensure project efficiency and quality of insight
*Anticipates key project risks.  Proactively develops and executes mitigating strategies effectively as required

OPERATIONAL
*If a People Leader, responsible for the 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
*Delegates and ensures completion of special assignments (e.g. job descriptions, handbook updates, SOP scientific consulting)
*Complies 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.