Early Development Global Regulatory Lead

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

📋 Description

• Offer strategic regulatory leadership on a global scale for designated early development initiatives.

• Formulate and implement global regulatory strategies that facilitate accelerated clinical development and First-in-Human objectives.

• Integrate patient-centric methods into regulatory planning and development strategies.

• Contribute to the growth, culture, and operational excellence of the Early Development Regulatory Team.

• Represent Regulatory Affairs in governance committees and development discussions.

• Collaborate with asset teams to transition programs from early to advanced development phases.

• Establish and improve regulatory processes, infrastructure, and operational efficiencies.

• Mentor, coach, and nurture members of the regulatory organization.

• Foster relationships with stakeholders in Clinical Development, Translational Medicine, CMC, Biometrics, Medical Affairs, Commercial, and Business Development.

• Keep abreast of and communicate changing global regulatory requirements and policies.

• Lead interactions with health authorities and manage external regulatory vendors.

• Assist with Scientific Advice procedures, INDs, CTAs, fast-tracked development procedures, and other regulatory activities.

• Provide regulatory expertise for business development evaluations, due diligence, and portfolio strategy discussions.

⛳️ Requirements

• A Bachelor's degree in Life Sciences, Pharmacy, Medicine, or a related scientific field.

• A minimum of 5-7 years of experience leading global regulatory strategies and teams.

• Extensive knowledge of global regulatory frameworks, with substantial experience involving FDA, EMA, and PMDA.

• Proven track record in supporting innovative therapies throughout early clinical development, including First-in-Human trials.

• Demonstrated ability in developing and executing global regulatory strategies.

• Experience in health authority interactions, Scientific Advice meetings, IND/CTA submissions, and expedited regulatory pathways.

• Strong leadership capabilities with the capacity to influence without direct authority in a highly matrixed environment.

• Exceptional verbal, written, presentation, and stakeholder management abilities.

• Strong project management, prioritization, and organizational skills.

• An advanced scientific degree (PhD, PharmD, MD, or equivalent) is preferred.

• Experience in both early and late-stage drug development is preferred.

• Scientific expertise in Immunology or related therapeutic areas is preferred.

• Familiarity with biologics, monoclonal antibodies, peptides, siRNA, and small molecules is preferred.

• Experience in integrating biomarker strategies, patient engagement initiatives, and patient-relevant evidence is preferred.

• Background in supporting business development transactions, portfolio assessments, and regulatory due diligence is preferred.

• Interest in utilizing AI-enabled and digital solutions is preferred.

• Legal authorization to work in Belgium, where the role is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.