Regulatory Affairs Manager, Europe Biologic SME
Core
Senior regulatory specialist managing European market applications, lifecycle management, and post-marketing submissions for biologic products.
Role type
Senior IC Regulatory Affairs Manager (Biologics, Europe)
Builds
Regulatory strategies, market applications, and lifecycle management activities for biologic products
Domain
Life Sciences / Biologics / European Regulatory Affairs
Required skills
European regulatory procedures, biologic product lifecycle management, market applications, variations, renewals, maintenance activities, labelling updates, CMC regulatory activities, stakeholder management
Preferred skills
CRO/consultancy experience, global cross-functional collaboration, customer-facing regulatory experience, multi-programme management
Technologies
Regulatory submission systems, CMC documentation tools
Responsibilities
Provide regulatory expertise for European market applications and post-marketing activities; Support development and execution of regulatory strategies; Prepare and review regulatory submissions; Identify regulatory risks; Collaborate with CMC, clinical, safety, quality, and project management stakeholders; Participate in customer interactions and governance discussions; Ensure regulatory deliverables meet quality and compliance expectations
Seniority
Senior, hands-on IC