Senior Global Regulatory Affairs Specialist

Senior Global 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 Senior Global 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:

You will take ownership of regulatory affairs deliverables, applying your expertise to complex challenges.

Key responsibilities include:

• Developing global regulatory strategies for the successful submission and approval of clinical trial applications and marketing authorizations.
• Providing regulatory guidance and support to cross-functional teams throughout the drug development process.
• Ensuring compliance with global regulatory requirements and standards.
• Managing regulatory submissions and interactions with health authorities.
• Participating in regulatory intelligence activities to stay updated on changes in regulations and guidelines.

Your Profile:

You will have a strong foundation in regulatory affairs, with the experience to work independently and guide others.

Required qualifications and experience:

• Bachelor's degree in a scientific discipline or related field.
• Minimum of 5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
• Strong understanding of global regulatory requirements and guidelines.
• Excellent communication and social skills.
• Ability to work independently and collaboratively in a fast-paced environment.

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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