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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, Merck 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, Merck 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 Merck 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)
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