Director, Regulatory Affairs, Europe
$204,000–$255,000 year
HybridBasel, Basel-City, Switzerland
Job Summary
Develop and execute regulatory strategies for Marketing Authorisation Applications across the EU, EEA, UK, and Switzerland for oncology programs in clinical development. Lead regional regulatory planning, oversee integrated filing plans, and direct MAA submissions including dossier readiness and cross-functional alignment. Serve as the primary liaison with European health authorities such as the EMA, MHRA, and Swissmedic, managing Scientific Advice Briefing Packages, Orphan Designation Applications, and Paediatric Investigation Plans. Identify and mitigate regulatory risks while partnering with global leads and cross-functional teams including R&D, Medical Affairs, and Safety. Monitor evolving European regulatory requirements and manage external vendors to ensure timely approvals.
Required Qualifications
- Degree in biological or life sciences, pharmacy, medicine, or related fields
- A minimum of 10 years in the pharmaceutical/biotech industry or relevant work experience
- A minimum of 8 years in Regulatory Affairs including a regulatory strategy role
- Deep understanding of European regulatory frameworks and oncology guidelines
- Demonstrated success in EMA/MHRA submissions and approvals, including but not limited to MAA, Paediatric, Orphan Designations experience
- Direct hands-on experience in the preparation and submission of large, complex regulatory documentation to support health agency review/approval procedures, post approval activities
- Experience interacting with the EMA and other European agencies
- Demonstrated experience in strategic problem-solving with health agencies and leading internal teams on regulatory strategy
- Experience in representing Regulatory Affairs on cross-functional teams and presenting to senior management
- Excellent interpersonal, written, and presentation skills with the ability to effectively communicate complex regulatory strategies to diverse audiences
- Thrives in fast-paced, dynamic environment and ability to multi-task independently with limited supervision
- Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines
- Excellent leadership, communication and stakeholder management skills
- Strong project management and organizational skills
Desired Qualifications
- An advanced degree (PhD, PharmD, MSc)
- Significant experience with oncology drug development highly preferred
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