About CSL

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Stellenbeschreibung

CSL Behring is a global biotherapeutics leader driven by its promise to save lives. In Bern more than 1600 employees develop and deliver life-saving therapies to treat people with rare and serious medical conditions worldwide.

For our location in Bern (Switzerland) or Marburg (Germany), we are looking for a

Manager, Global Regulatory Affairs Region EU & Switzerland (100%) (m/f/d)

Main Responsibilities and Accountabilities:

• Serve as Regulatory Regional Manager EU, to support product development and life cycle activities for the CSL Behring product portfolio as well as to support development of combination products, borderline products, Medical Devices, and Digital Health Apps.


• Act as responsible regulatory person for the implementation of EU MDR (Medical Device Regulation) in EU.


• Serve a contact to Notified Bodies for review of medical device related documentation.


• Contribute to the development of global regulatory strategies by providing expert knowledge on most efficient regional regulatory procedures and requirements.


• Strengthen global regulatory teams by providing expertise on regional regulatory guidelines and relevant Health Authority recommendations and assessments.


• Contribute to compilation of global and regional briefing packages for Health Authority meetings.


• Contribute to the compilation of relevant high quality documentation for submissions in the region, including applications for new licenses, variations, license renewals, pediatric plans, orphan drug designations, product identifiers/names and periodic reports according to agreed schedules.


• Take responsibility for management of regulatory procedures i.e. new license applications, renewal applications, variation applications, period reporting submissions, submissions required to fulfill regulatory post approval commitments.


• Ensure data entry and timely updates of data entries into regulatory systems.


• Establish and maintain working relationship to Health Authorities by efficient communication and effective use of negotiation skills to achieve positive outcomes for CSL Behring.


• Organize and participate in regional Health Authority interactions/meetings.

Qualifications & Experience:

• A degree in Life Science (at least BSc), Medical Science, or Pharmacy, preferably with a post-graduate qualification. Degree e.g. in Drug Regulatory Affairs advantageous.


• At least 4-5 years of regulatory experience in a regulatory authority-facing role, supported by additional pharmaceutical / Medical Device industry experience.


• Demonstrated working knowledge of regulatory guidelines and legislative requirements of both international and (relevant) regional Regulatory Authorities.


• Experience with Notified Body interactions is of advantage.


• Strategic and tactical thinking ability, complemented by a “hands on” operational approach and business planning orientation.


• Ability to identify the ‘big picture’ and opportunities/major issues and link day-to-day tasks with long-term goals.


• Demonstrated ability to lead and influence.


• Demonstrated sound judgment and flexible approach to managing situations with a strong Customer Service focus.


• Highly effective communicator with written, verbal and presentation skills in English.

We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.

CSL Behring is committed to provide equal employment opportunity for all.