The Global Regulatory Affairs department within the CoE Pharmaceuticals holds global responsibility for defining regulatory approval strategies and for the regulatory oversight of selected parenteral pharmaceutical products. Close collaboration with internal and external partners as well as consultants is essential, as is cross-country alignment of regulatory documentation within the Regulatory Affairs network.

Key Responsibilities:

• You lead and develop Global Regulatory Affairs, Label & Leaflet Design, as well as the associated global networks and shared services.
• You ensure pharmaceutical and medical device regulatory approvals in all relevant markets and are responsible for all variations to ensure compliance.
• You ensure compliance with and continuous development of IMS processes, SOPs, and all applicable national and international regulations.
• You structure regulatory processes, prioritize projects, and manage budgets, resources, and investments in line with divisional strategic objectives.
• You lead and develop employees and foster a performance-driven, well-connected regulatory affairs organization with a clear communication structure.
• You drive operational excellence and lean administration and ensure robust project and portfolio management.
• You actively promote the continuous development of expertise and IT technologies.

Professional Qualifications

• You hold a completed degree in a natural sciences discipline.
• You bring extensive regulatory affairs expertise for pharmaceuticals and medical devices in both national and international environments.
• You have proven leadership and governance experience in managing global, cross-functional organizations and networks.
• You possess strong compliance, quality, and process management competence.
• You have extensive experience in budget, resource, and IT system management within global regulatory organizations.

Personal Competencies:

• You demonstrate strong executive leadership capability with clear results and impact orientation.
• You show strategic decision-making strength and the ability to assess and manage complex regulatory matters under risk and compliance considerations.
• You possess outstanding communication and influencing skills in a global, multicultural stakeholder environment.
• You demonstrate a global mindset with pronounced intercultural competence and confidence in international contexts.