Manager, Regulatory Affairs (RA) & Compliance Switzerland (60 – 100%) (m/f/d)

CSL Behring Lengnau AG (Lengnau BE, Schweiz) Vor 3 Tagen veröffentlicht

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 the second largest influenza vaccine company 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!

CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat people with life-threatening medical conditions and to help them live full lives. The parent company, CSL Limited, is headquartered in Melbourne, Australia.

In May 2014, CSL selected Lengnau in the Canton of Bern in Switzerland as the location of a new manufacturing facility to support the commercial production of our promising novel therapies. In May 2020, CSL announced the strategic partnership with Thermo Fisher Scientific, the world leader in serving science. Thermo Fisher will lease and operate the Lengnau state-of-the-art biotech manufacturing facility once construction is completed in 2021. It is anticipated that employees at the site who are engaged for the operation of the site and the commercial production of our therapies in Lengnau will automatically transfer to Thermo Fisher Scientific once construction is complete.  Today, more than 200 employees work in Lengnau.

You can find more information on the strategic partnership with Thermo Fisher here and some more information about the prospects of a future career with Thermo Fisher here.

We are looking for talented and dedicated personalities that share our passion to develop and deliver innovative therapies. With your commitment, reliability and high-quality standards you help us to improve the quality of life for those in need.

We are currently recruiting for a

Manager, Regulatory Affairs (RA) & Compliance Switzerland (60 – 100%) (m/f/d)

Responsibilities:

  • Assist the Head of Quality Management and the Technical Responsible Person in his duties according to the Swiss “Medicinal Products Licensing Ordinance (MPLO) 812.212.1” to enable Site and Product Regulatory Compliance within the required timelines for the Lengnau site.
  • The position holder is the responsible Regulator Affairs (RA) person for the compilation, submission and maintenance of the site-specific Swiss establishment licenses (Site Regulatory Compliance).
  • The position holder is the primary RA contact person for regulatory affairs topics/questions from any customer. He/she develops and provides regulatory services within Commercial Operations for CH, EU, US and RoW markets (Regulatory Services and Product Regulatory Compliance).
  • The person is interfacing with relevant technical expert departments for the compilation and maintenance of facility and equipment information for regulatory submissions.
  • Additionally, the position holder may serve as a designated RA contact during GMP inspections and customer audits, and for preparation of such inspections and audits.

Qualifications:

  • University degree in natural sciences (BS/BA/MS or equivalent), a degree in Regulatory Affairs or Quality Assurance is advantageous.
  • Minimum of 5 years’ experience in the biotech or pharmaceutical industry, with at least 3 years in Regulatory Affairs.
  • Strong GMP compliance background would be an asset.
  • Sound knowledge in natural sciences with a focus on biological medicinal products.
  • Basic knowledge of the regulatory framework in at least one key region (US, EU, Japan, CH, Australia).

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.

Worker Type:

Employee

Worker Sub Type:

Regular
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Manager, Regulatory Affairs (RA) & Compliance Switzerland (60 – 100%) (m/f/d)

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