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 Development Products(m/f)
Responsible for regulatory decision making necessary to ensure planning and execution of successful global regulatory strategies, submissions and approvals for assigned projects
Provide tactical and strategic regulatory leadership and guidance for the Global Regulatory Affairs Strategy Team. Ensure understanding and worldwide alignment of regional regulatory strategies with the global regulatory strategy.
Accountable for the development and implementation of global regulatory strategies, the planning and execution of all regulatory agency submissions through all clinical development phases to product licensure/approval worldwide and through Phase 4 for assigned projects.
Responsible for overseeing and ensuring support to the regional regulatory strategic leads to ensure successful preparation and execution for key regulatory agency meetings.
Serve as the primary regulatory interface on the global Core Project Team and Clinical Development Team.
Accountable for the overall regulatory deliverables and milestones.
Mitigating regulatory risks whilst ensuring compliance with all global regulatory requirements.
Provide regulatory leadership to the development of the Target Product Profile and in the longer term product labeling. Responsible together with the Global Strategic Labeling Lead for the development and maintenance of the dCCDS/ DCCS.
Present, as required, regulatory plans, risk assessments and strategies, pertaining to the assigned projects, to senior review committees such as GRA Strategy Management Review Team, Project Review Committee, Project Strategic Groups and PharmaPlan.
A Postgraduate Degree in Pharmacy, Biology, Chemistry, Pharmacology, Clinical medicine or related life science is preferred (MS, PhD or MD). The ideal candidate will have a strong clinical foundation.
Minimum of 10 years of experience in the biotech or pharmaceutical industry, with at least 8 years in Regulatory.
Thorough knowledge and understanding of pharmaceutical/biological product development and regulatory requirements for product development and approval in more than one key region (EU, US, Japan).
Experience working in Regulatory Affairs in a global environment across two or more geographic areas (preferentially US and EU).
Extensive experience interfacing with regulatory agencies and proven skill at developing and implementing successful global regulatory strategies.
Experience in leading and managing matrix teams (minimum 3-5 years), setting clear direction, holding people accountable and fostering a collaborative team environment.
Strong leadership, verbal and written communication skills and a demonstrated ability to develop constructive and effective relationships with direct reports, colleagues and senior management.
Strong team player with the communication and organizational skills to interact seamlessly both internally and externally on strategic, operational and scientific matters.
Demonstrated ability to think strategically, create innovative strategies and able to anticipate future trends and consequences.
Creative problem solving/issue resolution skills with the willingness to take risks and act decisively.
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.
Interested? Then we are looking forward to receiving your comprehensive Online-Application.
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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.