Early Development Global Regulatory Lead

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

📋 Description

• Serve as a vital member of the EDRT, contributing to the establishment and growth of the team in accordance with argenx culture.

• Collaborate in the creation and execution of innovative global regulatory strategies.

• Ensure that patient-centricity is integrated into regulatory strategy.

• Represent the EDRT in key early development governance forums.

• Act as a liaison between the EDRT and asset teams to aid in the transition of programs.

• Provide mentorship and coaching to EDRT members.

• Foster relationships with internal stakeholders.

• Monitor, interpret, and communicate the evolving global regulatory landscape.

• Oversee the regulatory affairs vendors engaged in EDRT activities.

⛳️ Requirements

• A minimum of 15 years of regulatory affairs experience within biopharmaceutical organizations.

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

• PhD or PharmD is preferred.

• Previous experience in rapidly expanding pharmaceutical organizations is advantageous.

• Comprehensive understanding of the drug development process, particularly with orphan drugs.

• Ability to engage with scientists and clinicians effectively.

• Proven capability to coordinate the creation of regulatory documents.

• Experience in interactions with regulatory bodies, especially FDA and EMA.

• Knowledge of current and emerging regulatory legislation, industry trends, and global health care business practices.

• Highly developed organizational and project management skills.

• Exceptional presentation, written, and verbal communication abilities.

• Strong leadership skills with a demonstrated capacity to build, motivate, and develop a team.

🏝️ Benefits

• Competitive salary package.

• Broad range of benefits.