Manager Regulatory Affairs CMC (m/f)

Munich, Germany

Manager Regulatory Affairs CMC (m/f)

Are you familiar with the development and registration process of biopharmaceuticals? Are you working in a regulatory affairs environment? Are you familiar with eCTD Module 3 for Marketing Authorisation dossiers? And do you enjoy communicating with external development and service partners?

Then please continue reading …

Cinfa Biotech is the biosimilars company of Cinfa Group, a pharmaceutical leader in Spain with more than 50 years of experience, offering a broad portfolio of business lines. We develop, manufacture and commercialise high-quality biosimilars for oncology and inflammatory diseases.

With our headquarters in Pamplona, Spain and offices in Munich, Germany we are committed to highest European quality standards. We cover the entire pharmaceutical value chain from the manufacturing process development to clinical studies; and from regulatory strategy to commercialisation.

Our in-depth technical, clinical, regulatory and commercial expertise and European standards ensure the quality of our products. Highly efficient structures in our development and manufacturing processes enable us to quickly progress on our way to market. 

As part of the expansion of the regulatory affairs team in Munich we are seeking a committed

Manager Regulatory Affairs CMC (m/f).


You will be involved in

  • Design of regulatory strategy
  • All aspects of dossier preparation: Scientific advice procedures, dossier creation in close cooperation with R&D departments, maintenance and lifecycle management of dossiers
  • Personal interaction with health authorities
  • Communication with external partners and service providers


You convince us by

  • Successfully completed studies in natural sciences or comparable technical training
  • Several years of professional experience in the registration of medicinal products,
    ideally biopharmaceuticals
  • Active participation in the preparation of dossiers
  • Experience in CMC development for biopharmaceuticals


Are you interested?

Our team will be glad to help you and is available for establishing the initial contact by phone on +49 89 54 54 62-0. You can, of course, also directly send your application to career@cinfabiotech.com (Reference no.: 180208).


We ensure absolute discretion.

We look forward to your application.

 

Cinfa Biotech GmbH
Nymphenburger Str. 3c
D-80335 München

Phone +49 89 54 54 62 – 0
Fax +49 89 54 54 62 – 29
E-Mail career@cinfabiotech.com
www.cinfabiotech.com

 


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Cinfa Biotech S.L.

Travesía de Roncesvalles, 1
E-31699 Olloki (Navarra)
Spain

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