About the role
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.
- 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
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- Are you a current ICON Employee? Please click here to apply