Regulatory Submissions Manager

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.

We are currently seeking a Manager, Regulatory Affairs to join our diverse and dynamic team. As a Manager, Regulatory Affairs at ICON, you will play a pivotal role in contributing to drug development as part of the Regulatory Affairs team. You'll provide regulatory guidance and operational support across various stages of drug development, including early development, agency interactions, clinical trial applications, marketing applications, and post-approval staff.

What you will be doing

Lead regulatory activities and submissions independently, with prior experience in areas such as CTA/IND/MAA

Provide regulatory guidance and efforts to internal teams

Participate in agency interactions and regulatory submissions

Contribute to developing best practices within ICON Regulatory Affairs through your insight of regulatory processes and guidelines

Work collaboratively as part of a regulatory or cross-functional team, depending on project size and nature

Your profile

Bachelor's degree in a scientific or healthcare-related field advanced degree preferred

Minimum of 6 years of experience in regulatory affairs within the pharmaceutical or biotechNlogy industry

Prior experience with various regulatory submissions, including CTA/IND/MAA

Ability to lead internal teams and carry out regulatory activities independently

Strong understanding of global regulatory requirements and guidelines

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 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.

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