BeOne Medicines I GmbH is looking for a Senior Manager, Global Labeling Compliance & Connectivity to support global commercial labeling projects and programs. This role is central to enhancing labeling process effectiveness, efficiency, and compliance within the Global Regulatory Affairs Labeling Group. You will be responsible for planning, coordinating, and tracking key deliverables while driving cross-functional collaboration.
What You'll Do
- Monitor and update labeling provisions for SDEA contracts, coordinating with legal and country teams and taking action on any non-compliance.
- Perform data remediation activities and record quality events for the regulatory labeling team.
- Monitor assigned CAPAs until resolution, providing guidance to reduce recurrence.
- Drive cross-functional working groups to identify, assess, and implement improvements that reduce compliance risk and increase labeling process efficiency.
- Assist with the development, revision, and maintenance of departmental SOPs, work instructions, and non-governance documents.
- Prepare training and communications for stakeholders to ensure proper process execution.
- Report on and coordinate the timely availability of metrics and KPIs to demonstrate labeling process compliance and efficiency.
- Serve as a strategic liaison between Global Labeling Business Users and IT for new or enhanced technical solutions.
- Represent global regulatory labeling in company-wide initiatives as assigned.
- Identify industry trends and evaluate their impact on BeOne labeling policies and practices.
- Support the preparation of labeling deliverables for Health Authority submissions, market implementation, inspections, or audits on an ad-hoc basis.
- Communicate with a wide range of internal and external contacts, anticipating and resolving problems while keeping leadership updated on project status.
What We're Looking For
- A Bachelor’s degree in Project Management, Life Sciences, or a related area.
- A minimum of 6 years of pharmaceutical or biotechnology/device industry experience, with prior commercial regulatory labeling required.
- Direct working experience with labeling processes, document management, and international labeling execution differences such as translations and harmonization.
- Familiarity with Regulatory Information Management systems.
- Effective verbal and written communication skills.
- Ability to work cooperatively in a team and serve in a leadership capacity.
- Strong organizational skills, with the flexibility to handle multiple tasks under pressure while maintaining attention to detail.
- Proficiency in MS Office and Project Management tools is mandatory.
- Familiarity with GMP requirements and a good understanding of GxP/GMP applications.
Nice to Have
- Strong aptitude for authoring User Guidance, Standard Operating Procedures (SOPs), and managing change control.
- An advanced degree.
- Project management experience.
Technical Stack
- MS Office Suite
- Project Management tools
- Labeling implementation and tracking systems
- Document Management Systems
- Packaging and Artwork Management Systems
- Veeva Vault
- Change Management Systems
- SharePoint
Team & Environment
You will be a key member of the Global Regulatory Affairs Labeling Group, driving initiatives to enhance process compliance and efficiency across the organization.
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
