Strategist, GRA CMC

Strategist, GRA CMC

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

As a Senior Manager, Regulatory Strategy 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 oversee regulatory affairs operations, balancing quality, timelines, and stakeholder expectations.

Key responsibilities include:

• Developing and implementing regulatory strategies for global clinical trials.
• Providing expertise and guidance on regulatory requirements and compliance issues.
• Collaborating cross-functionally with teams to ensure regulatory objectives are met.
• Leading interactions with regulatory agencies and preparing submissions.
• Keeping abreast of regulatory updates and industry trends to inform strategy.

Your Profile:

You will have a strong background in regulatory affairs, with proven management experience and a commitment to quality delivery.

Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Minimum of 5 years of experience in regulatory affairs within the pharmaceutical or biotech industry.
• Strong knowledge of global regulatory requirements and guidelines.
• Proven track record of successful regulatory submissions and interactions.
• Excellent communication, leadership, and problem-solving skills.

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 specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers site 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, color, 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

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply