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 1 2,000 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
Regulatory Regional Manager EU EP (m/f)
The Regulatory Regional Manager is responsible for all regional regulatory strategic and operational tasks for a range of products already licensed in the region. This includes expansion into new markets.
Serve as regional regulatory strategist for allocated product portfolio.
Contribute to the compilation of relevant high quality documentation for submissions in the region, including variations, license renewals, and responses to questions, according to agreed schedules while taking into account regional specific requirements.
Lead the preparation and contribute to briefing packages for HA meetings. Responsible for performing regulatory procedures like new license applications, renewal applications, change applications, PSUR submissions, submissions of other documents required to fulfill regulatory post approval commitments and international Scientific Advice meetings in the region.
Act as a Subject Matter Expert on regional, regulatory procedures and HA requirements, develop and maintain effective working relationships with regional Regulatory Agencies demonstrated by high quality communication and effective use of negotiation skills to achieve positive outcomes for CSL Behring.
Degree in Biological or Medical Science or Pharmacy, preferably with a post-graduate qualification. Degree e.g. in Drug Regulatory Affairs advantageous.
At least 5 years of regulatory experience in a regulatory authority facing role.
Demonstrated working knowledge of regulatory guidelines and legislative requirements of both international and regional Regulatory Authorities.
Understanding of the principles of GMP, GCP and GLP.
Strategic and tactical thinking ability, complement ed by a “hands on” operational approach.
Customer service focus.
Highly effective communicator with written, verbal and presentation skills.
Planning, organizing and time management skills, as well as attention to detail; demonstrated ability to work across multiple disciplines.
Operate and manage projects with minimal to no supervision.
Fluent in English, fluent in German is an advantage.
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.
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.