Director Regulatory Affairs - Regulatory Intelligence & Policy

Responsibilities

• Accountable for Regulatory Intelligence and Policy in the EU, identifying and anticipating key regulatory trends affecting global business.
• Inform regulatory management of current and future developments and develop mitigation strategies to maximize business opportunities.
• Advise regulatory professionals and provide regular overviews of emerging developments via newsletters and presentations.
• Develop formal processes for reviewing and submitting comments on draft regulatory and scientific guidance documents to health agencies and committees.
• Lead interdisciplinary teams to discuss legislation and scientific guideline developments.
• Represent the company by interacting with EU trade associations and interest groups.
• Support the Business Development function during the Due Diligence process by providing EU regulatory expertise.

Requirements

• University Degree in Pharmacy, Medicine, Life Science, or Natural Science (PhD preferred).
• 8-11 years of experience in the pharmaceutical industry, clinical research organizations, or a regulatory health authority.
• 5-8 years of specific experience in Regulatory Affairs, including clinical trial applications and Marketing Authorization in Europe.
• Deep knowledge of European laws, regulations, and guidelines for human medicinal products.
• Fluency in both English and German.
• Proven ability to lead activities across multiple projects in a multinational organization.

Preferred Qualifications

• Post-doctorate or professional experience in pre-clinical research or clinical development.
• TOPRA diploma or a Master’s Degree in Regulatory Affairs.
• Experience in paediatric development.
• Knowledge of Medical Devices or In-vitro diagnostics.
• Proficiency in a third language.

About the Company

Daiichi Sankyo is a global healthcare company dedicated to improving lives through innovative medicines. With a presence in more than 30 countries, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. We foster a culture of mutual respect, continuous learning, and inclusion to shape a healthier future for patients worldwide.