Senior Regulatory Affairs Leader — Strategy & Team Coaching

KCR Placement; Antwerpen; On-site; EUR 90,000 - 130,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Regulatory affairs

Leadership

Project management

Communication

Coaching/mentoring

Education

Bachelor's degree in a relevant scientific discipline

Job description

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.