How you match
01Skills
02CommunicationNegotiationStrategic PlanningMentoringHealth Authority interactionsLifecycle managementPharmaceutical developmentrisk assessmentsRegulatory Compliance in MedicineTeam managementStakeholder engagementProject management software
The role
0301Defines, develops, and leads Regional progressive regulatory strategies
02Effectively communicates the regional regulatory strategies, submission plans and timelines
03Contributes to the development of team members and provides direction, support, mentoring
04Leads the Submission Working Group and represents the region as needed on global and project teams
05Manages, plans, and executes regional regulatory submissions in close alignment
Requirements
↳BSc. Advanced scientific related degree preferred; BA accepted based on experience
↳A minimum of 8 years of experience in drug regulatory affairs preferably within the EU region
↳Solid regulatory experience, including knowledge of regulations and guidance applicable in the region
↳Experience participating to or leading interaction with Health Authorities
↳Able to formulate regional regulatory strategy to achieve competitive and accelerated product approvals
Benefits
＋We offer interested people numerous opportunities
＋Strongly believe in, and promote, diversity, equity, and inclusion
