Senior Manager, Regulatory Affairs

ICON plc; Antwerpen; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

ICON is a global healthcare intelligence and clinical research organisation. As Senior Manager, Regulatory Affairs, you will design and analyse regulatory strategies, oversee submissions, and lead a team to deliver high quality regulatory deliverables across our portfolio.

You will mentor staff, coordinate cross-functional activities, engage with regulatory agencies, and advise clients on development plans and global regulatory pathways.

Qualifications

• Bachelor's degree in a relevant scientific discipline or healthcare-related field.
• EU/APAC: 7+ years regulatory affairs experience with supervisory roles in pharma/CRO.
• US/LATAM/CAN: 7+ years regulatory affairs incl supervisory experience and 6+ years pharma/CRO.
• Experience in regulatory strategy, documentation, MAA submissions, clinical trials, post-licensing activities, and agency interactions.
• Strong organizational, communication, leadership and presentation skills.

Responsabilités

• Oversee regulatory affairs delivery and coach the team.
• Contribute to strategic development and submission plans.
• Serve as regulatory affairs expert and advisor to ICON clients internally and externally.
• Represent the Regulatory Affairs Department in business development activities and generate new opportunities.
• Contribute to regulatory activities across the ICON portfolio, including areas like agency interactions and development planning.

Connaissances

Regulatory affairs

Leadership

Project management

Communication

Coaching/mentoring

Formation

Bachelor's degree in a relevant scientific discipline

Description du poste

Senior Manager - Regulatory Affairs

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 Manager, Regulatory Affairs 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:

Your focus will be on overseeing regulatory affairs delivery, coaching your team, and driving continuous improvement. Key responsibilities include:

• Participate in provision of regulatory expertise in strategic drug development across multiple areas.
• Take part in preparation of strategic development and submission plans.
• Be involved in the regulatory affairs activities across the ICON portfolio and be an expert and advisor to ICON clients (externally and internally).
• Be a trusted partner - represent the Regulatory Affairs Department in business development activities and generate new business opportunities.
• Contribute to at least two of the following areas: interactions with regulatory agencies, early phase consulting, development planning (PDP/RDP/CDP), scientific/agency advice, orphan drugs/pediatric development, medical devices

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
• EU/APAC: In-depth proven regulatory affairs expertise. Minimum of 7 years' experience, supervisory experience, and pharmaceutical/CRO industry experience.
• US/LATAM/CAN: A minimum of 7 years regulatory affairs experience including supervisory experience and a minimum of 6 years pharmaceutical/CRO industry.
• Demonstrable experience within regulatory affairs, including development of regulatory strategies, document writing, marketing authorization applications, clinical trials, post-licensing activities, and direct regulatory agency interaction.
• Strong organizational skills, ability to manage multiple tasks, and meticulous attention to detail.
• Excellent written, verbal, and management skills, as well as demonstrated presentation skills, problem-solving ability, strong interpersonal skills, and the ability to plan/organize.

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