This is a fully remote position, open to applicants in Belgium, +5 more countries.

📋 Description

• Manage the delivery of regulatory affairs

• Mentor the regulatory affairs team

• Foster continuous improvement initiatives

• Offer regulatory expertise in strategic drug development across various domains

• Engage in the formulation of strategic development and submission plans

• Participate in regulatory affairs tasks across the ICON portfolio

• Counsel ICON clients, both internally and externally

• Represent the Regulatory Affairs Department in business development efforts

• Create new business opportunities

• Contribute to interactions with regulatory bodies, early phase consulting, development planning, scientific/agency advice, orphan drugs/pediatric development, or medical devices

⛳️ Requirements

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

• EU/APAC: Extensive, proven regulatory affairs expertise

• At least 7 years of experience, including supervisory roles

• Experience in the pharmaceutical/CRO industry

• US/LATAM/CAN: A minimum of 7 years of regulatory affairs experience, including supervisory roles, and at least 6 years in the pharmaceutical/CRO sector

• Proven experience in regulatory affairs, including the development of regulatory strategies, document preparation, marketing authorization applications, clinical trials, post-licensing activities, and direct interaction with regulatory agencies

• Strong organizational abilities and capacity to manage multiple tasks

• Exceptional attention to detail

• Outstanding written, verbal, and managerial skills

• Proven presentation skills and problem-solving capabilities

• Excellent interpersonal skills and the ability to plan and organize

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