Global Regulatory Lead

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

📋 Description

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

• Advise the organization on filing strategies and coordinate across various disciplines to ensure timely submissions.

• Oversee regulatory affairs vendors involved in marketing authorization submissions and ensure high-quality engagements with regulators.

• Actively contribute to regulatory filings, including INDs, BLAs, MAAs, and other requested areas.

• Lead post-approval activities, encompassing drug registration, listing, and the payment of program user fees.

• Monitor, interpret, and convey changes to the global regulatory landscape.

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

• Collaborate with medical, legal, quality, pharmacovigilance, and distribution teams to provide timely regulatory input for business decisions.

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

• Foster relationships and collaborate across the organization to achieve company objectives.

• Lead, inspire, and develop a team within a matrix environment.

• Promote operational excellence and a positive company culture in a fast-paced, results-oriented environment.

⛳️ Requirements

• A minimum of 10 years of regulatory affairs experience in biopharmaceutical organizations.

• At least 5–7 years in global leadership positions focused on major regulatory regions such as the FDA, EMA, or PMDA.

• A PhD or PharmD is preferred.

• Previous experience in rapidly expanding pharmaceutical organizations is desirable.

• Comprehensive understanding of the drug development process.

• Expertise in orphan drugs.

• Knowledge of evolving regulations and guidelines, particularly in the United States.

• Proven ability to coordinate critical regulatory documents for medicine approvals, focusing on the FDA.

• Experience in engaging with regulatory authorities, especially the FDA and EMA.

• Strong affinity for science and the ability to engage with scientists and clinicians.

• Capacity to communicate with diverse individuals on technical and business topics.

• Familiarity with current and emerging regulatory legislation, industry trends, and global healthcare business practices.

• Highly developed organizational and project management capabilities.

• Demonstrated strengths in strategic planning, delegation, resource allocation, and workload prioritization.

• Exceptional presentation, written, and verbal communication skills.

• A proven track record of successful interactions with regulatory and health authorities.

• Established ability to build, motivate, and develop a team.

• Capability to combine strategic thinking with individual execution and team leadership within a matrix environment.

• Alignment with argenx values and a commitment to driving company culture.

🏝️ Benefits

• Reasonable accommodations for individuals with disabilities to participate in the job application or interview process, perform essential job functions, and receive employment benefits and privileges.

• Equal Opportunity Employer.