Regulatory Affairs Manager

4 weeks ago

England, United Kingdom ICON Strategic Solutions Full time

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

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