Regulatory Affairs Senior Manager, Regional CoE
Core
Leads operational delivery, governance, and performance of Lifecycle Management (LCM) activities for established products across multiple markets, ensuring compliant country-ready submissions and efficient hand-offs from local teams.
Role type
Senior IC Regulatory Affairs Manager (Regional CoE)
Builds
Country-ready regulatory dossiers, submission packages, and implementation plans for established products
Domain
Biopharmaceuticals / Regulatory Affairs
Required skills
LCM strategy execution, dossier customization, Health Authority question management, CMC change management, stakeholder influence, risk mitigation, process standardization, team leadership
Preferred skills
Regional hub management, Veeva RIM/ERV platform expertise, automation/digital workflow implementation, scaling across small molecules/biologics
Technologies
Veeva RIM, ERV, regulatory intelligence platforms
Responsibilities
Lead LCM portfolio delivery and governance; manage demand intake and prioritization; customize dossiers for country-specific requirements; coordinate Health Authority interactions and response management; oversee implementation of approved variations; drive process standardization and automation; mentor team members and build capability
Seniority
Senior, hands-on IC with matrix leadership responsibilities
