Global Regulatory Affairs Planning Group Lead

Bern, Switzerland

Posted: 15-Nov-2017

Ref#: CLS-0001

CSL Behring – the global biotherapies provider driven by its promise to save lives and to improve the quality of life for people with rare and serious medical conditions is looking for a

Global Regulatory Affairs Planning Group Lead

Main Responsibilities and Accountabilities:

  • Provides leadership and direction for the new Global Regulatory Affairs (GRA) Planning Group, responsible for executing the regulatory submission planning and registration tracking processes supported by various systems (new labeling tracking system, new GRA and enterprise planning systems, regulatory information management system) in adherence with internal procedures and compliance requirements. Staff and lead the newly formed group at our Bern and Marburg (Germany) locations.
  • Responsible for the implementation of our new centralized concept for maintenance and continuous improvement of the regulatory submission planning and registration tracking processes, striving for planning and tracking excellence. 
  • In addition to the group leadership purpose above, the incumbent will also be himself responsible for planning and tracking of regulatory events and milestones owned by regulatory affairs (specific milestones, dossier dispatch, submission and approval) in various systems as GRA Planning Specialists.
  • Support the GRA vision of excellence through good scientific practice, integrity and consistent compliance with regulatory standards.

Qualifications & Experience:

  • Bachelor in a scientific/technical discipline or equivalent
  • Function-related training in Regulatory Affairs
  • At least 5 years professional experience in Regulatory Affairs or equivalent
  • Experience in line management
  • Excellent oral, written and interpersonal communication skills in English in a multicultural environment

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.

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