Regulatory FSP Director CMC Lead - EMEA
Core
Senior Director providing technical and operational leadership for CMC regulatory services, supporting Functional Service Provider (FSP) teams and clients in the pharmaceutical/biotech industry.
Role type
Senior IC regulatory director (CMC)
Builds
CMC regulatory strategies, compliant deliverables, and managed FSP team outputs for client engagements
Domain
Life Sciences / Regulatory Affairs / CMC
Required skills
CMC regulatory affairs expertise, ICH guidelines knowledge, leadership and team development, budgeting and forecasting, business development support, resource planning, project oversight
Preferred skills
Local language skills, advanced computer skills (MS Office, Adobe Acrobat), process improvement capabilities
Technologies
Microsoft Word, Microsoft Excel, Adobe Acrobat
Responsibilities
Lead, coach, and develop staff including hiring, performance management, and mentoring; Provide CMC regulatory subject-matter expertise to internal and external clients; Advise clients on CMC regulatory strategy and product development; Serve as executive contact for key clients on CMC-related matters; Provide functional oversight and delivery support for CMC FSP teams; Support resource planning and forecasting across CMC work; Oversee project budgeting and forecasting; Collaborate with business development to secure new CMC and FSP business
Seniority
Director, strategic leadership & hands-on management