Senior Global Regulatory Affairs Specialist

ICON Clinical Research; Reading; Presencial; GBP 60.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Annual leave entitlements

Retirement planning

LifeWorks

Employee assistance

Descripción de la vacante

ICON plc in Reading, United Kingdom, is seeking a Senior Global Regulatory Affairs Specialist to lead regulatory strategy and submissions across global markets. You will interpret complex clinical and regulatory data, guide cross-functional teams, and ensure compliance with evolving guidelines.

With 5+ years in regulatory affairs, you will own development plans, liaise with health authorities, and stay ahead of regulatory intelligence to support timely approvals and patient access.

Formación

• Bachelor's degree in a scientific discipline or related field.
• Minimum of 5 years of experience in regulatory affairs within the pharmaceutical/biotech 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.

Responsabilidades

• Develop global regulatory strategies for successful submissions and marketing authorizations.
• Provide regulatory guidance to cross-functional teams throughout drug development.
• Ensure compliance with global regulatory requirements and standards.
• Manage regulatory submissions and interactions with health authorities.
• Participate in regulatory intelligence activities to stay updated on changes.

Conocimientos

Regulatory affairs

Global regulatory knowledge

Communication skills

Independent worker

Collaborative

Educación

Bachelor's degree in science

Descripción del empleo

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.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well‑being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements




• A range of health insurance offerings to suit you and your family’s needs.




• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.




• Global Employee Assistance Programme, LifeWorks, offering 24‑hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well‑being.




• Life assurance




• Flexible country‑specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Visit our careers site (https://careers.iconplc.com/benefits) to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (https://careers.iconplc.com/reasonable‑accommodations)