Head of Regulatory Affairs France f/m

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 anddefine 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.Please send your application (cv & letter) in English.Who you are:University degree or PhD in pharmacy5years minimum of experience in regulatory affairs field (local RA proficiency) and in positioning leading high-performance teamsExcellent and up to date knowledge and understanding of applicable EU and French regulationsWell established network with local Health AuthoritiesStrong stakeholder management, project management and communication skillsAbility to manage time effectively, gain alignment and successfully execute future strategic activitiesAbility to focus on implementing measurements and taking corrective actions on processes managementBe comfortable, understand how to assess & evaluate the impact of change within a team/organizationEffectively prioritizes competing tasks in a fast-paced and dynamic environmentHigh proficiency in French and English Ability to interact effectively with all levels of managementEffective time management skills to multi-task several initiatives with demonstrated ability to achieve successAdvanced skills in with all standard MS office & business applicationsAvailability to travel is needed #J-18808-Ljbffr