Regulatory Affairs Specialist

Regulatory Affairs Specialist

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

As a Regulatory Affairs Specialist at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.

What You Will Do:

Your role will involve delivering regulatory affairs work to a high standard, working closely with your team and stakeholders.

Key responsibilities include:

• Undertaking variable duties based on project requirements, primarily within Pharmaceutical, Biotechnology, or Biologics Regulatory Affairs, with potential involvement in related areas.
• Contributing to regulatory submissions team activities, including preparation, compilation, and submission of regulatory documents such as CT/IND, MAA/NA, variations/lifecycle submissions, DSUR, PSUR, renewals, and agency briefing documentation.
• Managing and implementing label review, translation requirements, fee calculations, and other aspects for regulatory submissions.
• Providing input to the Regulatory Intelligence function and participating in readability testing.
• Reviewing IMPD/IB Core Docs and labeling for clinical trials.
• Collaborating with Regulatory Submissions team or cross-functional teams based on project size and nature.
• Facilitating business development activities as needed.

Your Profile:

You will bring relevant regulatory affairs experience, along with the following qualifications and skills.

Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field.
• Familiarity with label review, translation requirements, and regulatory intelligence activities.
• Strong attention to detail and excellent communication skills.

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply