Global Regulatory Affairs CMC Team Lead

Bern, Switzerland

Posted: 15-Nov-2017

Ref#: CLS-0002

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 CMC Team Lead

Main Responsibilities and Accountabilities:

  • The GRA CMC Team Lead manages, oversees and develops a team of CMC regulatory professionals and is accountable for CMC regulatory tasks related to product development, registration and license maintenance for the products handled by the team. He/she ensures consistent approaches and development of best practices. The position holder may deputize for the GRA CMC Site Lead.
  • As a Change Control Expert, the GRA CMC Team Lead is accountable for the timely regulatory assessment of CMC changes, technical changes related to facility and equipment and/or plasma changes in the Global Change Control (GCC) system in accordance with global regulatory requirements and in close cooperation with GRA Regions. He/she is the first contact point for relevant local technical expert departments regarding regulatory questions related to change control, and may represent GRA in local and global change panels. 
  • The position holder may represent GRA in local change projects affecting multiple products. In this role he/she will coordinate and consolidate input from all relevant regulatory functions.
  • As a Facility & Equipment Expert, the GRA CMC Team Lead is the primary GRA contact point interfacing with relevant technical expert departments for the compilation and maintenance of facility and equipment information for regulatory submissions. 
  • The position holder may represent Global Regulatory Affairs in Core Project Teams for CMC projects as an expert for regulatory questions related to facility and equipment. The position holder is the primary GRA contact during GMP inspections and for preparation of inspections. He/she coordinates all incoming questions from an inspection within GRA. 

Qualifications & Experience:

  • University Degree in natural sciences, further education specialized in Regulatory Affairs would be an asset.
  • Minimum 5 years’ experience in biotech or pharmaceutical industry with a minimum of 3 years’ experience in Regulatory Affairs.
  • A first experience in line management.
  • Sound knowledge in natural sciences with a focus on biological medicinal products would be an asset. 
  • Sound technical regulatory expertise and understanding of the regulatory framework in more than one key region (US, EU, Japan, CH, or Australia).
  • Fluent German and 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.

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