Regulatory Affairs Associate Director – EU Regulatory Lead

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

📋 Description

• Deliver strategic, operational, and tactical regulatory insights on both pre-approval and post-approval activities.

• Direct filing strategies and coordinate various disciplines to ensure timely submissions to EMA and relevant EMEA agencies.

• Supervise regulatory affairs vendors engaged in marketing authorization submissions.

• Actively participate in regulatory filings and associated activities.

• Provide regulatory leadership for post-approval processes.

• Monitor, analyze, and communicate updates regarding the global regulatory environment.

• Function as a regulatory affairs business partner to local commercialization teams.

• Collaborate with medical, legal, quality, pharmacovigilance, and distribution teams to offer regulatory guidance for business decisions.

• Align assigned project-team strategies with broader global regulatory and development objectives.

• Lead the review process and deliver technical guidance for regional and global regulatory submissions.

• Offer regulatory strategy advice and technical expertise to both internal and external clients.

• Oversee key client projects to ensure high-quality performance.

• Manage project budgeting and forecasting activities.

• Identify out-of-scope contract tasks and facilitate contract modifications.

• Work alongside business development on pricing, new business presentations, proposals, and budgets.

• Lead matrix/project initiatives, providing training and support for junior team members.

• Ensure adherence to organizational and departmental SOPs and WPDs.

• Engage in and lead launch, review, and project-team meetings.

• Spearhead departmental initiatives and project teams.

• Serve as a liaison with local regulatory authorities and clients.

• Travel occasionally to both domestic and international sites.

⛳️ Requirements

• An advanced degree is required; a PhD or PharmD is highly preferred.

• Equivalent to 12+ years of experience; at least 10 years in regulatory affairs within pharmaceutical companies.

• A strong focus on EMA regulatory frameworks.

• Experience with at least one end-to-end regulatory submission process, ideally following the centralized procedure.

• Experience in rapidly expanding pharmaceutical organizations is a plus.

• In-depth understanding of the drug development lifecycle.

• Proven expertise in orphan drug development.

• Familiarity with the global regulatory landscape, especially in Europe, Switzerland, the UK, Israel, and the Middle East.

• Capability to lead and coordinate essential regulatory documents for medicinal product approval and lifecycle management, including EU regulatory strategies and PIPs.

• A history of successful interactions with regulatory and health authorities.

• Proficiency in English, both written and verbal, as well as the local language where applicable.

• Exceptional attention to detail, quality, and strong editorial and proofreading skills.

• Advanced computer proficiency, including Microsoft Word, Excel, and PowerPoint.

• Strong organizational, time management, and planning abilities.

• Professional negotiation skills.

• Ability to work independently and make independent judgments.

• Advanced knowledge of regulatory requirements and procedures related to clinical trial authorization, licensing, and lifecycle management.

• Expertise in ICH and other global regulatory guidelines.

• Comprehensive understanding of regulatory specialty areas such as preclinical, clinical, CMC, and publishing.

• Advanced comprehension of medical terminology, statistical concepts, and guidelines.

• Strong analytical, investigative, and problem-solving abilities.

• Knowledge of budgeting and forecasting processes.

• Executive presence, along with consultation and presentation skills.

• Equivalency through a combination of relevant education, training, and/or directly related experience may be considered.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.