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

Merck - avec plus de 300 ans de progrès et plus de 38000 employés dans le monde, se positionne en leader sur le marché Pharmaceutique, Chimique, et des Sciences de la vie. Avec passion, engagement et innovation, nous poursuivons un objectif commun : améliorer la qualité de vie. C'est pourquoi nous avons besoin de vous!

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