Global Regulatory Affairs Director - Swedish Orphan Biovitrum - Sobi - Avslutad

We are looking for a Global Regulatory Affairs Director, who will be overall responsible for the regulatory work to obtain and maintain marketing authorizations through submissions and communication to/with regulatory authorities, for both Sobi products and Partner Products. The work requires extensive internal as well as external communication and co-ordination.

 

Key responsibilities

  • Managing responsibility for the regulatory SPP team, which is a part of Global Regulatory Affairs
  • Being an expert on processes, applications and regulatory environment to achieve and maintain marketing authorizations
  • Developing regulatory strategies
  • Participating in the Leadership Team of the department as well as the Leadership Team of the Business Unit
  • Collaborating with partners whose products Sobi distributes
  • Budget responsibility
  • Participating in strategic and regulatory evaluations of in-licensing matters

Desired Experiences

  • Degree in Life Sciences
  • Several years of experience from the pharmaceutical industry or competent authority (regulatory, development, maintenance).
  • Managing experience
  • Excellent communication skills and good ability to work in teams. Fluency in Swedish and English.

Personal attributes

  • Professional, flexible and result orientated. Living up to the Sobi values by acting in a collaborative, accountable, respectful and engaged manner. 

Location:  The position is based in Stockholm.

MORE INFORMATION AND APPLYING

If you want more information or have questions please call Knut Natt och Dag at +46 722 166 800. Send us your application at knut.nattochdag@aktivia.se as soon as possible due to our ongoing efforts with this recruitment. Please include “Global Regulatory Affairs Director” in the subject field.

Sobi

Sobi is an international specialty healthcare company dedicated to rare diseases. Our mission is to develop and deliver innovative therapies and services to improve the lives of patients. The product portfolio is primarily focused on Haemophilia, Inflammation and Genetic diseases. We also market a portfolio of specialty and rare disease products for partner companies across Europe, the Middle East, North Africa and Russia. Sobi is a pioneer in biotechnology with world-class capabilities in protein biochemistry and biologics manufacturing. In 2014, Sobi had total revenues of SEK 2.6 billion (USD 380 M) and about 600 employees. The share (STO: SOBI) is listed on NASDAQ OMX Stockholm. More information is available at www.sobi.com.

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