Regulatory Affairs Manager

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.

As a Regulatory Manager, you will work in Global Regulatory Affairs team, a successful and driven team that provides consultancy for all ICON projects globally as well as stand-alone contracts with clients. You will manage Regulatory Affairs activities on regulatory projects and clinical trials undertaken by ICON. You will be independent, able to effectively manage matrix teams and have regulatory project management experience.

The role

• As member of the Regulatory Affairs team, you will contribute to at least one of the following activities, working under established procedures and mainly under supervision, however with the ability to work independently for routine activities and submissions :

  • Preparation, compilation and submission of routine Regulatory submissions supporting the conduct of clinical trials globally

  • Contribute to more complex projects (early development, MAA, Post Marketing) contributing to review and compilation of documents for Scientific advice/variations/MAA, document product label review, translation requirements, fee requirements and payments, submission planning

  • Support Regulatory Intelligence

  • Peer review, QA and/or checking, as appropriate, of documents prepared by other professionals within SRS

  • Communicate /liaise with clients, regulatory agencies / competent authorities and/ or other regulatory or functional experts on designated regulatory activities as required

  • Support to more senior team members on more complex projects

  • Identify issues, proactively seek advice and address them in a timely manner, including development of preventative actions (as necessary under supervision)

  • Assist in review or update of existing department standard operating procedures

  • Develop and maintain a current awareness of regulatory requirements through publications, seminars and appropriate training courses as deemed necessary

  • Maintain an accurate record of the time associated with each allocated activity and ensure compliance with all timekeeping and tracking systems

What you need

• A minimum of a Bachelor's degree or local equivalent

• Minimum of 5-7 years in Regulatory Affairs in the Pharmaceutical or CRO industry would be advantageous

• Experience in Gene and Cell Therapy desirable

• People managing experience advantageous

• Ability to multi-task, & support various projects

• Be able to solve problems in pro-active and timely manner

• Encourages and initiates teamwork. Respects diversity, values the opinions of others. Leverages teams' strengths, empowers and delegates appropriately

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.

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