Senior Manager, Regulatory Affairs

This is a fully remote position, open to applicants in Belgium, +8 more countries.

📋 Description

• Manage the delivery of regulatory affairs.

• Mentor the regulatory affairs team.

• Promote ongoing improvements.

• Offer regulatory expertise in strategic drug development across various domains.

• Engage in the creation of strategic development and submission plans.

• Support regulatory affairs initiatives throughout the ICON portfolio.

• Act as a specialist and advisor for ICON clients, both externally and internally.

• Represent the Regulatory Affairs Department in business development initiatives.

• Generate new business prospects.

• Contribute to at least two areas such as regulatory agency interactions, early phase consulting, development planning, scientific/agency advice, orphan drugs/pediatric development, and medical devices.

• Design and evaluate clinical trials, interpret intricate medical data, and assist in developing innovative treatments and therapies.

⛳️ Requirements

• Bachelor’s degree in a relevant scientific discipline or healthcare-related field.

• EU/APAC: Extensive proven expertise in regulatory affairs.

• At least 7 years of experience with supervisory roles in EU/APAC positions.

• Experience in the pharmaceutical/CRO industry for EU/APAC positions.

• US/LATAM/CAN: Minimum of 7 years of regulatory affairs experience, including supervisory roles.

• US/LATAM/CAN: At least 6 years of experience in the pharmaceutical/CRO industry.

• Proven regulatory affairs background, including the development of regulatory strategies, document writing, marketing authorization applications, clinical trials, post-licensing activities, and direct engagement with regulatory agencies.

• Strong organizational skills with the ability to manage multiple responsibilities.

• Exceptional attention to detail.

• Excellent written, verbal, and management capabilities.

• Proven presentation skills.

• Strong problem-solving abilities and interpersonal skills.

• Capability to plan and organize effectively.

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension schemes.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career paths.