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The Head of Global Regulatory Affairs – CMC (GRA-CMC) is accountable for strategic oversight of the Global Regulatory Affairs- CMC (GRA-CMC) function, through inspirational leadership and expertise. This critical role reports directly to the Head of GRA and collaborates and partners with other Regulatory Affairs functions, R & D Quality, The Company’s Biopharma Quality, Manufacturing and Supply Chain, and Pharmaceutical development functions in a dynamic international organization and other pharmaceutical companies in the context of Trade and Regulatory Associations.
• Development of a best in class, fully integrated Global Regulatory Affairs CMC (GRA-CMC) team, providing leadership with a strong focus on behaviors that cultivate collaboration, innovation, and results-orientation.
• Collaboration and partnership of the GRA-CMC function with other regulatory functions, R & D Quality, Biopharma Quality, Manufacturing & Supply Chain, and Pharmaceutical Development functions.
• Collaboration with stakeholders on a senior level, e.g., GRA and GMS leadership teams, supervisory committees of partners, regulatory authority senior managers
• Representation of the company in industry associations and public conferences with a goal to share knowledge and the company’s positions (upon request).
• Development of the functional regulatory CMC strategy for all products concerned, whether or chemical or biological nature, or combination of both, from R & D to life-cycle management, ensuring consistency with program strategy, implementation, and communication of the strategy.
• Setting GRA-CMC objectives at a departmental and functional level in alignment with the relevant stakeholders using a top-down/bottom up approach
• Evaluation of functional CMC key performance indicators and supervision of implementation of corrective and preventative actions
• Oversight of the functional business processes such as standard operating procedures, work instructions, and related tools
• Functional CMC budget management including functional resource and budget planning, talent management and continued development for employees
• Accountable and responsible for the approval of regulatory documents and part 3 and 2.3 of dossiers for new Marketing Authorization parent dossier.
• Act as a spokesperson for negotiations with senior staff at global health authorities for all CMC related issues.
• Provides Strategic Input into the CMC portion of the Regulatory Strategy Document (RSD)
• Minimum of 10 years pharmaceutical experience with a least 5 years of global CMC regulatory experience.
• Experience with leading teams within a Matrix Organization
• Strong people management and leadership skills at a group level with a focus on building consensus through negotiation and best practices
• Collaborates across multiple functions and within the department in Leadership teams
• Track record of oversight that spans research & development projects as well as life cycle management projects
• Ability to ensure that the Global CMC Regulatory Strategy ii consistent with the Global Regulatory and overall portfolio strategy
• Practical experience in one or more of the following areas for biotech molecules: manufacturing process development, transfers, validation or analytical development, quality management
• In-depth knowledge of global pharmaceutical legislation
• Excellent written and spoken communication skills in English (knowledge of other European languages is an asset such as German)
What we offer: We empower you to fulfill your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!