CSL Behring is one of the world's leading manufacturers and providers of innovative, life-saving pharmaceuticals made from human plasma as well as related treatments. The company has approximately 12,000 employees globally, of which there are about 2,300 in Germany at the largest production and research location of CSL Behring in Marburg.
People who work for CSL Behring are committed to saving the lives of patients throughout the world. This involves top performance, as we strive to be the best. Join our team in the Global Regulatory Affairs department as a
Global Regulatory Lead EP(m/f)
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 moderate/major 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 the product family and all other concerned GRLs as applicable.
Managing projects related to more than one product family.
Providing as CMC lead strategic input to DP GRAST and ensuring that state of the art innovative regulatory strategies are followed, continuous risk analysis is performed, mitigations are proposed and appropriate high quality documentation is provided regarding CMC.
Provides RA input to CMC project feasibility and other strategic/subject matter assessments as required.
Lead EP Global Regulatory Affairs Strategy Team. Serve as primary regulatory interface for the assigned product family. Provide high quality strategic regulatory input to CMC LCM-Core Project Teams and be accountable for overall regulatory deliverables and milestones.
As CMC Lead provide high quality strategic regulatory advice for CMC matters of established products under further clinical development and ensure necessary high quality documentation for submissions is provided according to agreed schedules taking into account regional specific requirements. Contribute to and participate at HA meetings as applicable.
Generate and maintain a submission schedule for each product, reflecting all scheduled submissions and communicate submission schedules within GRA and other departments.
Ensure that registration activities for the international active substance/excipient business are well coordinated.
Act as subject matter expert, evaluate draft guidelines and write impact assessment, select additional reviewers and create final response document.
Advanced scientific degree/Ph.D. and preferably degree in Regulatory Affairs.
At minimum 8 year 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 and in managing within a matrix management environment is a benefit.
Excellent communication, project management, planning, problem solving, presentationskills.
Keeps a team focussed to deliver according to agreed milestones, can inspire and motivate while providing corrective feed-back, if required.
Demonstrates strong organizational skills.
Anticipates future trends and proactively takes their impact into consideration. Is future oriented, can create innovative, competitive andcompelling strategic plans and comfortably dealswith concepts and complexity.
Demonstrates cross cultural sensitivity, handles and is comfortable with diversity.
Fluent in English.
What you need to know CSL Behring offers an adequate, performance-oriented salary with an attractive bonus system as well as an excellent company retirement plan consisting of early pension schemes and a top-notch supplementary retirement provision. Our employees also have the benefit of flexible working hours. In order to optimally coordinate career and family, we offer an option at our day-care centre for small children, as well as school vacation care for school-aged children and an option for caregiver leave.
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Über CSL Behring GmbH
CSL Behring ist weltweit einer der bedeutendsten Hersteller und Anbieter von lebensrettenden Arzneimitteln aus Humanplasma sowie verwandten Therapeutika. Das Unternehmen beschäftigt weltweit ca. 6.000 Mitarbeiter, davon rund 1.900 in Deutschland. Der größte Produktions- und Forschungsstandort von CSL Behring befindet sich in Marburg.