Manager Regulatory Affairs Advisory / Life Sciences (m/w/d)
Core
Advise Life Sciences clients on optimizing approval processes, implementing digital workflow solutions, and enabling AI usage in regulatory processes.
Role type
Manager, Regulatory Affairs Advisory (Life Sciences)
Builds
Regulatory Intelligence platforms, RIM systems, eDMS solutions
Domain
Life Sciences / Regulatory Compliance / Digital Transformation
Deliverable
client delivery
Required skills
Regulatory Affairs expertise, GxP compliance knowledge, Project leadership, Process design, Gap analysis, International regulatory requirements knowledge
Preferred skills
Experience with Veeva RIM, eDMS solutions, Team management
Technologies
Veeva RIM, eDMS, Regulatory Intelligence platforms
Responsibilities
Analyze regulatory requirements and develop actionable processes and governance structures; Lead process design for RIM and eDMS implementations; Manage client communication and project execution; Evaluate complex regulatory needs to create business and organizational models.