About the job
About the Organization
My client is a leading global pharmaceutical company seeking an experienced Labeling Manager to join their Munich operations. They are at the forefront of developing innovative therapies including small molecules, biologics, and combination products.
Position Overview
The successful candidate will join their established regulatory affairs team, playing a crucial role in managing global labeling operations and regulatory submissions. This position offers hybrid working arrangements based in Munich.
Key Responsibilities
Strategic Leadership
- Drive cross-functional team activities for Company Core Documents (CCDs) impact assessments
- Deliver strategic input on labeling initiatives
- Present recommendations to governance bodies
- Act as the global point of contact for labeling matters
Regulatory Management
- Own the preparation and submission of EU Product Information (PIs) for:
- MRP/DCP procedures
- Centrally Approved Products (CAPs)
- Urgent labeling updates
- Evaluate and manage local label deviations from CCDs
- Interface with health authorities and device registration bodies
Documentation & Compliance
- Oversee RIM database maintenance for:
- Labeling workflows
- CCD dispatches
- EU CAP products
- Global registration tracking
- Support regulatory inspections and audits
- Ensure compliant documentation of all labeling activities
- Stay current with regulatory requirements and guidelines
Stakeholder Management
- Collaborate with external suppliers and internal teams
- Coordinate responses to Health Authority inquiries
- Provide regular updates to global labeling governance
- Manage cross-functional relationships
Required Qualifications
- Bachelor’s degree minimum in:
- Pharmaceutical Science
- Engineering
- Related scientific field
- Advanced degree preferred
- Demonstrated experience in pharmaceutical labeling
- Strong regulatory affairs background
- Excellent project management capabilities
- Fluent English communication skills
Desired Experience
- EU regulatory procedures (MRP/DCP/CAP)
- RIM systems expertise
- Leadership of cross-functional teams
- Combination product regulatory knowledge
The Opportunity Offers
- Leading role in a global pharmaceutical company
- Flexible hybrid working model
- International exposure
- Professional development opportunities
- Competitive compensation package