Global Regulatory Lead – Early Development

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

📋 Description

• Deliver strategic, operational, and tactical regulatory insights for designated programs, with an emphasis on first-in-human planning and early clinical development.

• Formulate and convey global regulatory strategies for early clinical initiatives, encompassing regulatory pathways for initial clinical trials and critical early development milestones.

• Counsel teams on regulatory obligations and development strategies, including how the nonclinical package informs first-in-human determinations.

• Represent the regulatory function on assigned project teams and relevant governance committees.

• Collaborate with scientists, clinicians, and cross-functional partners to streamline regulatory activities and offer timely feedback.

• Contribute to regulatory documentation and submissions, including INDs, CTAs, scientific advice requests, and other early development filings.

• Facilitate high-quality interactions with health authorities, particularly the FDA and EMA, and assist teams in preparing for these discussions.

• Act as a liaison between project teams, the client’s early development organization, and the broader global regulatory and development teams.

• Monitor, analyze, and relay changes in global regulations, guidelines, and health authority expectations.

• Oversee regulatory vendor management to ensure high-quality deliverables and effective health authority interactions.

• Contribute to improvements in regulatory processes and operational methodologies.

• Provide support to colleagues through mentoring and sharing of knowledge.

⛳️ Requirements

• At least 10 years of regulatory affairs experience in biopharmaceutical companies.

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

• Comprehensive understanding of drug development processes.

• Strong global regulatory experience in early clinical development, particularly in first-in-human planning and initial clinical trials.

• Capability to shape global regulatory strategies for early clinical programs and translate those strategies into actionable development plans.

• Proficiency in evaluating how the nonclinical package supports first-in-human decisions.

• Experience in coordinating regulatory documents and submissions that support early clinical development, with a specific focus on the FDA.

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

• Knowledge of orphan drug development and the dynamic regulatory landscape, especially within the United States.

• Scientific curiosity and the ability to engage effectively with scientists and clinicians on both technical and business matters.

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

• Strong organizational and project management abilities, including strategic planning, prioritization, and coordination across multiple projects.

• Excellent written and verbal communication skills, with the ability to present complex regulatory concepts and influence stakeholders effectively.

• A collaborative mindset towards building relationships and partnering across different functions.

• Ability to operate effectively in a fast-paced, results-oriented, and highly accountable environment.

• A pragmatic, creative, and hands-on approach that combines strategic thinking with independent and collaborative execution.

• PhD or PharmD preferred.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.