Senior Global Regulatory Affairs Specialist

• Location: UK, Reading
• 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.
• Additional Locations: Spain, Madrid, Poland, Warsaw, Bulgaria, Sofia, Ireland, Dublin