Director Regulatory Affairs Oncology (m/f/d)

Bei Daiichi Sankyo stehen wir vereint hinter einem einzigen Ziel: Das Leben auf der ganzen Welt durch innovative Medikamente zu verbessern. Mit aktiver Innovation seit 1899, Präsenz in mehr als 30 Ländern und über 19.000 Mitarbeitern entwickeln wir bahnbrechende Therapien in der Onkologie, für Herz‑Kreislauf‑Erkrankungen, seltene Krankheiten und Immunerkrankungen. Im Einklang mit unserer Vision 2030, "ein innovatives globales Gesundheitsunternehmen zu sein, das zur nachhaltigen Entwicklung der Gesellschaft beiträgt", gestalten wir eine gesündere, hoffnungsvollere Zukunft für Patienten, ihre Familien und die Gesellschaft.

Purpose of the function

To serve as European Lead providing regulatory strategy support for assigned projects, products and non‑project work. Act as a regulatory specialist in the therapeutic area of oncology. Represent Regulatory Affairs internally working on a collaborative basis both within Europe and globally as a member of multi‑disciplinary global product teams, providing expertise on regulatory matters. Represent Regulatory Affairs in external interactions (e.g. authorities, affiliates, partners, CROs), providing expertise for regulatory strategy to achieve regional and global company goals.

Roles and Responsibilities

• Act as European regulatory lead supporting assigned projects in different stages of clinical development (early Phase 1‑Phase 3) covering product development plans, clinical trial and marketing authorization applications (MAA) as well as product life cycle management.
• Develop and lead regulatory strategies for drugs and biologics, including orphan drug designation (ODD), paediatric development plans (PIP), clinical trial applications, submission dossiers for MAAs, and interactions with national European Health Authorities and EMA.
• Represent European Regulatory Affairs in cross‑functional global project teams, initiatives, and towards collaboration partners.
• Oversee European registration activities, including regulatory roadmaps, document and dossier reviews, coordination with Health Authorities, and supervision of regulatory service providers.
• Act as regulatory contact person for national Health Authorities and EMA for assigned projects.
• Monitor changes and evolution in the regulatory landscape for relevant products and product classes, new regulations impacting assigned projects and communicating to relevant stakeholders.

Education & Experience

• University degree in life sciences (medicine, pharmacy, chemistry, biotechnology, biology or equivalent), Master and/or PhD preferred. Master Degree in Regulatory Affairs is a plus.
• Minimum of 10 years of professional experience in Regulatory Affairs in relevant roles/positions in pharmaceutical, clinical‑stage biotech, regulatory consultancy, or health authority environment with emphasis on early stages of clinical drug development.
• Strong experience to develop, plan, coordinate, and lead activities to implement regulatory strategies and agreed project timelines for drugs and biologics, including strategies for regulatory risk mitigation.
• Strong experience of submissions of marketing authorization applications (MAA), orphan drug designations (ODD), paediatric development plans (PIP), and clinical trial applications in Europe.
• Solid experience acting as Contact Person for Health Authorities, including preparing and leading Health Authority meetings and interaction.
• Very good knowledge of regulatory laws and regulations, including CTR, as well as being familiar with documents for regulatory submissions, and being familiar with European transparency rules in conjunction with CTAs and MAAs.
• Experienced managing simultaneously on multiple complex projects in a matrixed, multicultural global environment.
• Proactive, hands‑on, solution‑and detail‑oriented mindset.
• Excellent written and oral communication skills in English, second language preferred.

Warum Sie bei uns richtig sind

Bei Daiichi Sankyo zu arbeiten, ist mehr als nur ein Job – es ist Ihre Chance, das Leben von Patient*innen zu verbessern. Dieses ehrgeizige Ziel können wir nur gemeinsam erreichen. Deshalb pflegen wir eine Kultur des gegenseitigen Respekts und des kontinuierlichen Lernens, die von Vielfalt und Inklusion geprägt ist. Hier haben Sie die Möglichkeit, sich weiterzuentwickeln, mutig zu denken und Ihre Ideen einzubringen. Sie arbeiten proaktiv und möchten sich für die Bedürfnisse von Patient*innen einsetzen? Dann bewerben Sie sich jetzt!