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

Head of Regulatory Affairs France (m/f), LyonAs the Regulatory Affairs Head France, you will lead, build and manage a team of 2 Regulatory Affairs professionals. You will oversee and coordinate the day-to-day activities for the Regulatory department in France.Your responsibilities include:Leading local submission management from planning to finalizing local submissions and defining the Health Authority (HA) engagement strategy, serving as the point of contact for local Health Authorities.Maintaining a close relationship with the local HA and including HA insights into local strategic planning.Acting as the representative in the local industry association.Developing country product plans based on global/regional strategy and business plans, and communicating closely with partners and key stakeholder functions at local, regional, and global levels.Providing relevant support for clinical trials as applicable and required.Leading and coaching the team, engaging them to work efficiently and proactively, and enabling their development to reach their full potential.Reviewing, validating, certifying, and submitting promotional material by delegation of the Head Pharmacist.Leading regional projects or initiatives as a member of the Regional Regulatory Leadership Team.ProfileTo be successful in this role, you should have:A university degree or PhD in pharmacy.A minimum of 5 years of experience in the regulatory affairs field (local RA proficiency) and in leading high-performance teams.Excellent and up-to-date knowledge and understanding of applicable EU and French regulations.A well-established network with local Health Authorities.Strong stakeholder management, project management, and communication skills.The ability to manage time effectively, gain alignment, and successfully execute future strategic activities.The ability to focus on implementing measurements and taking corrective actions on process management.Comfort in assessing and evaluating the impact of change within a team/organization.The ability to effectively prioritize competing tasks in a fast-paced and dynamic environment.High proficiency in French and English.The ability to interact effectively with all levels of management.Effective time management skills to multi-task several initiatives with demonstrated success.Advanced skills in all standard MS Office and business applications.Availability to travel as needed. #J-18808-Ljbffr