Director (m/f/d) Regulatory Affairs - Regulatory Intelligence & Policy

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

Accountable for the performance of Regulatory Intelligence and Policy in the EU and the achievement of internal and external deliverables by providing regulatory intelligence and information management and effective communication and reviewing and interpreting regulatory and scientific regulations, directives, guidelines and initiatives. Overall management of Regulatory Intelligence for DSE using publicly available or internal information sources, paid databases in access and networking (e.g. vfa, efpia). Communicate important changes and trends within Regulatory Affairs, working with counterparts in Regulatory Intelligence in other regions as well as with other internal functions when required.

Roles and Responsibilities

• Planning tasks: Represent EU Regulatory Intelligence collaborating with US, Japan and other counterparts in Global Regulatory Affairs to identify and anticipate key regulatory trends of relevance emerging from the EU region or affecting the EU and global business and Daiichi Sankyo development activities.
• Decision tasks: Inform regulatory management of current and future developments in the regulatory environment and agree impact on Daiichi-Sankyo business and its current practices. Develop guidance and mitigation strategies to mitigate risks and maximize opportunities for Daiichi-Sankyo’s business.
• Executive tasks: Advise regulatory professionals and proactively manage all aspects of Regulatory Intelligence both internal and external to DSE: Conduct or oversee the Regulatory Intelligence activities in the region and provide regular over views of the current and emerging regulatory developments using e.g. newsletters, presentations as well as on special communication issues, where appropriate. Draft and revise SOPs and SOIs, if required for management review. Develop a formal process for reviewing and submitting comments on draft regulatory and scientific guidance documents and submit in agreement with manager to governments, regulatory health agencies and committees, enabling Daiichi-Sankyo voice to influence and shape future regulatory legislation, guidelines and policy. Support training needs of associates/managers in Regulatory and provide regulatory education on EU guidance and procedures working with counterparts globally, people’s managers and other functions in the department such as Procedural Management and Clinical Trial Offices. As assigned by manager, support Business Development function during Due Diligence process providing EU regulatory expertise and Regulatory Intelligence as requested. Lead interdisciplinary teams to discuss in depth relevant legislation and scientific guideline developments and identify risks and opportunities of particular interest to Daiichi Sankyo, manage any commenting process and external communication process. As agreed with regulatory management, lead and represent Daiichi Sankyo interacting with EU trade associations and interest groups.

Skills And Additional Requirements

• Knowledge of Medical Devices/In-vitro diagnostics is recommended.
• Excellent interpersonal skills.
• Ability to communicate and work across functions effectively in a multinational organization to accomplish results.
• Be "detailed-oriented" with a good oversight, well organized and self-motivated.
• Proven ability to plan, coordinate and lead activities simultaneously on multiple projects.
• High ethical behavior.
• High Computer proficiency (e. g. MS office, document management systems and databases).
• Excellent written and verbal communication skills in English and German, a third language would be 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!