Regulatory Affairs Specialist

As a Regulatory Affairs Specialist  you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Duties will be variable depending on the nature of the projects to be undertaken. These will mainly fall within the areas of Pharmaceutical, Biotechnology or Biologics Regulatory Affairs but may be in other related areas.
  • As member of the Regulatory Submissions team, you will contribute to at least one of the following activities:
  • Preparation, compilation and submission of CT /IND, MAA I NOA. Variations/ lifecycle submissions, DSUR, PSUR, renewals, agency briefing documentation
  • Management and Implementation of label review, translation requirements, fee requirements etc. for regulatory submissions
  • Input to the Reg Intel function
  • Readability testing
  • IMPD / IB Core Doc review, labelling review for CT
  • May work either as part of Regulatory Submissions team or as part of a regulatory or cross-functional team depending on the size and nature of project
  • May support business development activities

You are:

• G-Bachelor's Level Degree
• 2-3 year of experience 
• Office Save

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.