Associate Director, Regulatory Strategy

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The Associate Director, Regulatory Affairs provides key support to the Regulatory Affairs department. This position has primary responsibility for coordination and assembly of regulatory documents for review and submission to health authorities (primarily the FDA, other regulatory agencies as needed) and assists GRLs with strategies and submissions as appropriate. The Associate Director, Regulatory Affairs will be responsible for maintaining and updating archival copies of health authority submissions (e.g., IND, BLA, and MAA). The Associate Director, Regulatory Affairs will ideally have a working knowledge of regulatory requirements specific to key regions such as the US, Canada, and EU, and have a general awareness of current global trends in Regulatory Affairs.

• Under the direction of a senior Regulatory staff member, prepare, compile review, and submit documents for the company, including but not limited to initial INDs/CTAs/BLAs and amendments or supplements.
• Assist regulatory management and project teams in the implementation of regulatory plans and timely delivery of regulatory documentation.
• Develop, maintain, and communicate timelines for regulatory submissions.
• Participate in the review of critical documents such as: protocols, ICFs, IBs, CSRs, DSURs, etc. to ensure they are compliant with relevant regulations and guidance (e.g., ICH, FDA, EMA, etc.) prior to submission.
• Coordinate with Regulatory Operations to gather and assemble information necessary for submissions to health authorities in accordance with regulations and guidelines.
• Maintain databases of regulatory information, submissions and correspondence.
• Follow general instructions to complete projects while independently planning daily work to complete time sensitive assignments.
• Review, write, and present guidelines and SOPs as needed to support high quality submissions and assure adherence to regulatory requirements.
• Maintain current knowledge of applicable US and global regulations, guidance, and standards for drug development and product registration.

• Bachelor’s Degree
• 10-14 years of relevant experience
• Advanced knowledge of regulations, guidance, and environment for product development, new registrations and lifecycle maintenance activities
• Ability to assess impact of evolving information and provide guidance.
• Advanced knowledge of drug development and lifecycle.
• Advanced knowledge of review and approval processes of applicable regulatory Health Authorities.
• Strong knowledge of how the pharmaceutical industry works
• Excellent written and oral communication skills.
• Excellent attention to detail.
• Demonstrates advanced ability to have a flexible approach and adapt to change.
• Advanced ability to plan, organize and deliver multiple projects, according to agreed deadlines.
• Advanced ability to understand complex issues and propose creative and achievable solutions.
• Advanced ability to apply skills to determine risk exposure and communicate potential issues to management

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, 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.