Associate Director, Regional Regulatory Liaison, EEMEA

This is a fully remote position, open to applicants in Belgium.

📋 Description

• Accountable for leading the development and execution of regulatory strategies for pipeline assets within the EEMEA region.

• Aids in prioritizing countries and ensures efficient regulatory submissions and approvals, facilitating a smooth transition to product launch.

• Formulates regional and country-specific regulatory strategies for new product filings and Life Cycle Management (LCM) activities (e.g., new indications, significant variations), aligning these priorities with business goals, local regulatory affairs teams, and all pertinent regional/global stakeholders/governance committees.

• Assigned to critical pipeline programs, ideally starting from Phase IIa (Proof of Concept, PoC) until the final country launch in the region.

• Acts as the single Point of Contact (POC) for designated products for country regulatory teams, HQ teams, and regional stakeholders, including Business, Market Access, and Medical departments.

• Remains informed about the company’s pipeline filings, relevant regional and local regulations, and guidelines, while gathering pertinent regulatory information (regulatory intelligence) for the region and keeping stakeholders adequately updated.

• Responsible for leading the development of Health Authority responses in collaboration with the response team for new product filings and Life Cycle Management (LCM) activities (e.g., new indications, significant variations).

• Collaborates with all stakeholders to guarantee seamless planning and execution according to prioritization, resulting in high-quality and compliant regulatory submissions, timely management of Health Authority inquiries, on-time approvals, and successful launches.

• Offers assistance for New Indications and/or Major Variations that affect product launch.

• Leads, contributes to, and represents the region in regional/global projects, identifying any internal process and/or communication gaps and either resolving them or escalating them to regional and global stakeholders for resolution.

⛳️ Requirements

• Must possess a BS degree and/or a Master’s or Ph.D. in pharmacy or another life science field.

• At least 5 years of experience in the regulatory field or a comparable role.

• The candidate should have knowledge and experience in Regulatory Affairs, including regulations, registration guidelines, and regulatory processes for new product submissions and Life Cycle Management in general, and preferably within the intended region.

• Ability to integrate an AI/Digitalization mindset into daily work practices.

• Competence in understanding and navigating scientific content.

• Exceptional communication skills (both verbal and written) in English.

🏝️ Benefits

• Flexible Work Arrangements: Not Applicable