Head of Regulatory Affairs France (m/f), Lyon

Our passion for science and technology drives our approximately 62,000 employees in 65 countries to address some of today’s toughest challenges and develop more sustainable ways of living.

In our rapidly changing and uncertain world, factors such as an aging population, chronic diseases, AI, climate change, and other megatrends have created an appetite for scientific breakthroughs that can make a positive difference across our global society. The pace of change will increase over coming decades as technologies evolve and converge in ways that fundamentally transform how we live and work. For us at Merck, change is not a threat but an opportunity as we have proven for over more than 350 years.

Your role

• As the Regulatory Affairs Head France, you lead, build and manage a team of 2 Regulatory Affairs professionals. You oversee and coordinate the day-to-day activities for the Regulatory department in France.
• You lead the local submission management from planning to finalizing local submissions and define the Health Authority (HA) engagement strategy, and you serve as point of contact for local Health Authorities. You maintain a close relationship with the local HA and include HA insights into local strategic planning.
• You act as the representative in the local industry association.
• In your role you develop country product plans based on global/regional strategy and business plans. You communicate closely with partners and key stakeholder functions at local, regional, and global level, as applicable. As applicable and required, you provide relevant support for clinical trials.
• As Regulatory Head France you lead and coach the team, engage to work efficiently and in a pro-active manner. You enable the development of your team members, support their personal growth to reach their full potential. You review, validate, certify and submit promotional material by delegation of the Head Pharmacist.
• You lead, as applicable, regional projects or initiatives as a member of the Regional Regulatory Leadership Team.

Profile

• University degree or PhD in pharmacy
• 5 years minimum of experience in regulatory affairs field (local RA proficiency) and in positioning leading high-performance teams
• Excellent and up to date knowledge and understanding of applicable EU and French regulations
• Well established network with local Health Authorities
• Strong stakeholder management, project management and communication skills
• Ability to manage time effectively, gain alignment and successfully execute future strategic activities
• Ability to focus on implementing measurements and taking corrective actions on processes management
• Be comfortable, understand how to assess & evaluate the impact of change within a team/organization
• Effectively prioritizes competing tasks in a fast-paced and dynamic environment
• High proficiency in French and English
• Ability to interact effectively with all levels of management
• Effective time management skills to multi-task several initiatives with demonstrated ability to achieve success
• Advanced skills in with all standard MS office & business applications
• Availability to travel is needed