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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive regulatory affairs expertise with a focus on global leadership in biopharmaceuticals, particularly in early development programs and regulatory strategy. Proven ability to mentor teams, develop innovative regulatory strategies, and effectively communicate with stakeholders.
Highest-signal resume keywords
Global Regulatory LeadershipRegulatory Strategy DevelopmentDrug Development ExpertiseRegulatory Affairs ExperienceStakeholder Relationship Building
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory AffairsDrug DevelopmentIND/CTA ActivitiesScientific AdviceRegulatory FilingsClinical Development PhasesPatient EngagementBiomarker StrategyOrphan DrugsInnovative Medicines
Soft Skills
Influential CommunicationOrganizational SkillsProject ManagementMatrix LeadershipTeam Development
Certifications & Qualifications
PhDPharmD
Industry Keywords
FDAEMAPMDABiopharmaceuticalsHealthcare Business PracticesFirst-In-Human StudiesExpedited PathwaysCross-Functional TeamsRegulatory GuidelinesPatient-Centricity
About the role
Key responsibilities & impact- Serve as a key member of the global Early Development regulatory team
- Provide global regulatory leadership for assigned early development programs
- Develop regulatory strategies, identify risks, and align cross-functional teams
- Implement innovative global regulatory strategies through the end of first-in-human studies
- Embed patient-centricity in regulatory strategy
- Represent the team in early development governance forums
- Facilitate transition of programs between the early development regulatory team and asset teams
- Develop infrastructure and process improvements
- Mentor and coach team members
- Build relationships with internal stakeholders
- Monitor, interpret, and communicate evolving global regulatory requirements
- Oversee regulatory affairs vendors and regulator interactions
- Contribute to regulatory filings including Scientific Advice, INDs, and other requested areas
Requirements
What you’ll need- Minimum 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 FDA, EMA, or PMDA
- Strong understanding of drug development, early clinical development, first-in-human studies, orphan drugs, and regulatory strategy for innovative medicines
- Proven ability to develop global regulatory strategies supporting early asset progression and regulatory interactions
- Experience across early and late clinical development phases
- Experience with scientific advice, IND/CTA activities, expedited pathways, and other early development regulatory milestones
- Strong scientific mindset and ability to engage with scientists, clinicians, and cross-functional development teams
- Complementary expertise across antibodies, peptides, siRNA, and small molecules
- Experience integrating biomarker strategy, patient engagement, and patient-relevant evidence into regulatory and development plans
- Strong understanding of global regulations, guidelines, regulatory expectations, and healthcare business practices
- Clear and influential written, verbal, and presentation communication skills
- Highly developed organizational and project management skills
- Strong matrix leadership skills, relationship-building, stakeholder influence, team development, and outcome delivery
- Pragmatic, creative, hands-on approach with ability to execute under challenging timelines
- Candidates must be located in Belgium or Switzerland
- Advanced scientific degree such as PhD or PharmD preferred
Benefits
Comp & perks- Short-term incentives program eligibility
- Long-term incentives program eligibility
- Inclusive equal-opportunity employment environment