Plans and manages regulatory activities on both new and in-line products in accordance with health authorities. Defines or ensures registration strategy and planning. Organizes the preparation, submission and follow-up of medical affairs and authorities. Organizes and archives registration files. Ensures that all the aspects of the product safety are closely monitored and fulfill theregulatory requirements.
- Responsible for overseeing all relevant regulatory CMC aspects for multi-site/multi- product projects in scope across the CSLB global manufacturing network to ensure:
- efficient license maintenance
- timely new registrations in additional countries
- Chairs the Global Regulatory Affairs Strategy Teams (GRAST) for assigned projects to ensure alignment of the regional specific requirements to a global strategy. Accountable regarding CMC for successful regulatory license applications and product life-cycle management in close co-operation with the GRAST members, ensuring that state of the art innovative regulatory strategies are followed, continuous risk analysis is performed, mitigations are proposed and appropriate highquality documentation is provided regarding CMC.
Responsible and accountable for:
- Ensuring GRA representation and collaboration with key internal stakeholders of life-cycle management CPTs to ensure successful planning and execution of global regulatory strategies for assigned products.
- Overseeing and facilitating strategic planning of complex changes, scheduling of all submissions, classification and agreement on supporting documentation for changes and new license applications with the Regions and the timely filing by the regions.
- Partnering with internal stakeholders to get input and promote understanding of global strategies
- Ensuring information and knowledge sharing across GRA.
Provides RA input to CMC project feasibility and other strategic/subject matter assessments as required.
Advanced scientific degree / Ph.D. and preferably degree in Regulatory Affairs.
- At minimum 8 years of experience in the pharmaceutical industry, preferably in Biologics in the areas R&D, quality, manufacturing, Regulatory Affairs.
- Extensive regulatory technical expertise across a range of project types and products with demonstrated capability to develop global regulatory strategies
- Significant regulatory planning and submission experience across multiple Health Authorities/regions.
- Prior experience working cross-culturally.
- Prior experience in managing within a matrix management environment is a benefit