FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in developing EU regulatory strategies and leading clinical study submissions while ensuring compliance with emerging legislation. Proven ability to build relationships with regulatory agencies and stakeholders to align business objectives with regulatory requirements.
Highest-signal resume keywords
EU Regulatory Strategy DevelopmentClinical Trial Applications SupportStakeholder NegotiationEuropean Medicines Agency ExperienceRegulatory Compliance Monitoring
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 StrategyClinical Study SubmissionCompliance ActivitiesClinical DevelopmentPost-Approval ActivitiesAgency QueriesStudy Start-UpScientific AdviceOrphan DesignationPaediatric Investigation Plans
Soft Skills
Excellent Written CommunicationExcellent Verbal CommunicationRelationship Building
Certifications & Qualifications
Advanced Degree in Scientific Discipline
Industry Keywords
European Medicines AgencyNational Regulatory AgenciesContract Research OrganisationsLate-Stage Clinical StudiesEmerging EU Legislation
About the role
Key responsibilities & impact- Develop EU-appropriate regulatory strategies with development teams and regulatory management.
- Lead clinical study submissions, agency queries, compliance, start-up, and maintenance activities.
- Represent Regeneron with contract research organisations across complex late-stage clinical studies.
- Support business partners in aligning EU regulatory strategy with business objectives.
- Monitor emerging EU legislation and guidance, supporting company awareness and compliance.
- Build relationships with the European Medicines Agency, national agencies, and alliance partners.
- Lead early and late-stage regulatory strategy for timely end-to-end study conduct.
- Champion innovative EU pathways and share expertise across global regulatory and development teams.
- Collaborate with development teams, clinical teams, business partners, contract research organisations, and regulatory agencies.
Requirements
What you’ll need- Advanced degree in a scientific discipline.
- At least two years’ regulatory experience across clinical development and post-approval activities.
- Proven experience supporting EU Clinical Trial Applications through approval and study start-up.
- Direct experience with national regulatory agencies and leading face-to-face agency meetings.
- Clear stakeholder negotiation and excellent written and verbal communication skills.
- European Medicines Agency experience, including scientific advice, orphan designation, or paediatric investigation plans, is advantageous.
Benefits
Comp & perks- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits (e.g. medical, dental, vision, life and disability)
- Paid time off
- Family support benefits
- Reasonable accommodation during the recruitment process for applicants with known disabilities or chronic illnesses, where required