Regulatory Affairs Manager

Regulatory Affairs Manager- (EU CTR) Homebased in UK/Ireland Only

Due to recent success within one our Innovative Biotech Clients I am recruiting for a Regulatory Affairs manager at ICON - Working in a client-dedicated yet fully embedded role ICON’s Regulatory Strategy group, you will lead or contribute to the development and execution of the drug development strategy of our client’s new therapeutics.

The ideal candidate would have experience in EU CTR and making regulatory submissions via CTIS. You will be supporting the EU regulatory team with planning and executing regulatory submissions for allocated studies.

Prior experience working on oncology studies would be preferred.

You will play a key role in:

Providing strategic support, submission study milestone tracking, core document version control, HA Query management, and reporting and providing advice to the product development team.

While not directly responsible for submissions, this role provides program-level oversight and support across internal and external providers.

• • Prepare, review and support submissions to HA/Regional CTA Hub, in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.
  • Providing submission strategy
  • Expert knowledge of current CTA guidelines and regulations is preferred, as well as the ability to understand new guidelines and regulations as they are issued by major regulatory authorities in the region.

You are:

Adaptable, collaborative and an expert in regulatory CTA's.

Here at Icon we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:

• B.S./B.Sc is in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered.
• In-depth understanding and proven execution of CTA and Central Ethics processes globally
• Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards

Why 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.

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.

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, colour, 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.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.