Regional Regulatory Affairs Manager

As a CClinical Trial Application Submission Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Clinical Trial Application Submission Manager

What you will be doing:

• Prepare, review and support Pfizer submissions to HA/Regional CTA Hub, in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.
• Responsible for the co-ordination of translations for core documents required for submission
• Manage the compilation for core package build, contributing to CTA and authoring documentation as required
• May act as local country liaison when required
• Escalate, inform, and resolve any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities.

You are:

• 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.