The specialist will ensure regulatory compliance and delivery of the local regulatory milestones for the assigned range of products of the Company portfolio (from early development to Marketing Authorization submission and post-licensing activities):
Ensure compliance on Promotional activities in line with the legislation and with the Company procedures to support Business units' projects.
Contribute actively to the RA strategy of the company
Ensure an EU role to support Global Regulatory Affairs in EU regulatory activities
Ensure local regulatory compliance with the Company procedures and in line with the French legislation by:
Taking in charge promotional activities for the assigned range of products:
By reviewing the promotional campaign along the process and ensuring regulatory compliance to avoid rejections from the health authorities
By taking part actively in handling potential issues with the French Health authorities (ANSM) and/or Bayer competitors.
By timely updating the legally required texts on promotional documents. Ensuring timely, with high quality and properly documented, submission of:
applications for new Marketing Authorization, line extensions and new indications, or any submissions linked to Life Cycle Management activities (LCM)
renewals in order to keep Marketing Authorizations valid in the country
approved products /MRP/DCP
Manage the activities of the Department to ensure RA compliance, safeguarding the public Health
Ensure LCM of the existing authorizations
Ph.D. or M.Sc. degree in life science with a Master in Regulatory affairs
Experience in a similar regulatory function
Ability to be flexible to manage frequent and sudden (sometimes urgent) changes.
Fluency in English
Good communications skills, with adequate negotiating, interpersonal and influencing skills
Ability to drive projects
Leadership and open minded