Associate (m/f/d) Regulatory Affairs - EU Regulatory Procedural Management

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.

Location

The position can be filled at one of our European affiliates, with a preference for placement in Germany.

Purpose of the function

Provide support for EU Regulatory Procedural Management for assigned projects including all pre‑ and post‑authorisation activities ensuring a smooth run of regulatory procedures as well as regulatory compliance. Act as a representative at project teams assigned, working with EU regulatory strategy leads, with affiliates, license partners and others to support procedural delivery of the projects.

Roles and Responsibilities

• Support assigned regulatory submissions during development and life cycle management, in alignment with Regulatory Strategists, for European and other assigned non‑EU authorities
• Serve as a link between Regulatory Strategists, Product Support, and other disciplines in RA (e.g. RA‑CMC, Labelling, Regulatory Operations)
• As assigned, represent EU Regulatory Procedural Management in global regulatory and development teams and provide EU regulatory procedural guidance and operational strategy for assigned projects
• As assigned by superior, act as the regulatory contact person for authorities pertinent to procedural matters
• Support internal communications on regulatory status for the assigned assets
• Ensure consistency across projects and global alignment/synergies
• Participate in assigned non‑project tasks designed to enhance the operations and processes of Regulatory Affairs
• Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives

Education, Experience & Additional Requirements

• University Degree in Pharmacy, Life Sciences, Natural Sciences or Medical Science, preferably Master
• Master degree in Regulatory Affairs preferred
• Minimum of 1-2 years of experience in Regulatory Affairs; experience with EMA and CAPs preferred
• Experience of working in a global environment in interdisciplinary teams is a plus
• Proven ability to plan, coordinate and lead activities simultaneously on multiple projects
• Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organisation
• Ability to develop and maintain good relationships, challenge views, present and argue cases in a professional and respectful manner
• Solution and detail‑oriented; well organised and self‑motivated
• Strong working knowledge of Microsoft Office
• Excellent written and oral communication skills in English, second EU 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!