Early Development Global Regulatory Lead

This is a fully remote position, open to applicants in Belgium, +1 more country.

📋 Description

• Act as a vital member of the global Early Development regulatory team.

• Offer global regulatory leadership for designated early development initiatives.

• Formulate regulatory strategies, assess risks, and coordinate cross-functional teams.

• Execute innovative global regulatory strategies through the conclusion of first-in-human studies.

• Integrate patient-centricity within the regulatory strategy.

• Represent the team in early development governance meetings.

• Aid in the transition of programs between the early development regulatory team and asset teams.

• Create infrastructure and processes for improvement.

• Mentor and guide team members.

• Establish relationships with internal stakeholders.

• Observe, analyze, and communicate evolving global regulatory requirements.

• Supervise regulatory affairs vendors and interactions with regulators.

• Contribute to regulatory submissions including Scientific Advice, INDs, and other requested areas.

⛳️ Requirements

• At least 15 years of regulatory affairs experience within biopharmaceutical companies.

• A minimum of 5–7 years in global leadership positions focusing on key regulatory regions such as FDA, EMA, or PMDA.

• Solid understanding of drug development, early clinical development, first-in-human trials, orphan drugs, and regulatory strategies for innovative medicines.

• Demonstrated capability in developing global regulatory strategies that support early asset progression and regulatory interactions.

• Experience spanning early and late clinical development phases.

• Familiarity with scientific advice, IND/CTA activities, expedited pathways, and other early development regulatory milestones.

• Strong scientific acumen and the ability to engage with scientists, clinicians, and cross-functional development teams.

• Complementary knowledge across antibodies, peptides, siRNA, and small molecules.

• Experience in integrating biomarker strategy, patient engagement, and patient-relevant evidence into regulatory and development plans.

• Comprehensive understanding of global regulations, guidelines, regulatory expectations, and healthcare business practices.

• Effective and influential written, verbal, and presentation communication skills.

• Highly developed organizational and project management abilities.

• Strong matrix leadership capabilities, relationship-building, stakeholder influence, team development, and delivery of outcomes.

• Practical, creative, hands-on approach with the capacity to execute under tight timelines.

• Candidates must reside in Belgium or Switzerland.

• An advanced scientific degree such as a PhD or PharmD is preferred.

🏝️ Benefits

• Eligibility for short-term incentives program.

• Eligibility for long-term incentives program.

• Inclusive equal-opportunity employment environment.