Head of CMC Regulatory Affairs within Biologics, Xbrane

xbrane-logo-simple-kopia-5

Do you have experience from a global role within CMC Regualtory affairs within Pharma? Do you have the skills to take the overall responsibility for CMC for newly developed and developing biological products? Xbrane is taking their first products to the market. Join the team!

As Head of CMC Regulatory Affairs you will have a key role and overall responsibility for all CMC activities for Xbrane’s biological products.

Responsibilities include:

  • Development & maintenance of a CMC strategy for Xbranes biosimilars.
  • Coordinate, compile and submit regulatory submissions
  • Contract management for CRO:s within regulatory affairs.
  • Communication with relevant authorities. Prepare for & participate in scientific advice.
  • Ensure compliance with relevant regulations for global markets, e.g Europe, USA and Asia.

Xbrane have six more products in the pipeline that are in earlier phases of clinical development. As Head of CMC Regulatory Affairs you manage the entire portfolio from a CMC perspective, from pre-clinical stages to post-market. You will be the first in-house resource in CMC and will be working with both strategic and operative tasks.

Xbrane is an innovative company with in-house research and development. You will have a key role in the transition from start-up to an established pharmaceutical company.

Terms: The position is open-ended, starting upon agreement.

Location: Xbrane headquarters in Solna

Qualifications

To manage the CMC regulatory affairs we believe that you have:

  • extensive experience from CMC in a global role within pharma as e.g. project manager, global lead, senior RAM or director/associate director. Alternatively you have a senior role as consultant or within a pharmaceutical authority within CMC.
  • Experience from biological pharmaceuticals from a CMC perspective.
  • developed & maintained CMC strategies.
  • High proficiency in English is required. Knowledge in Swedish is meriting.

In addition to you knowledge and experience you have the ability to lead & communicate all activities related to CMC biologics at Xbrane. You are independent, get things done and have the perseverance to achieve goals. You are pragmatic and can easily switch between strategic and operative tasks.

Is this you? Welcome to contact us!

Application & Information

In this recruitment Xbrane collaborate with Search4S, Recruitment Consultant Anna Rennermalm. For more information call Anna Rennermalm, +46 70 794 20 05.

Send you application, labelled “Xbrane CMC” to apply@search4s.se at the latest 2017-02-26.

Applications will be reviewed continuously.

About Xbrane

Xbrane is a biopharmaceutical company specialized in high demand biosimilars and long acting injectables. The segment has a high entry barrier, driven by high production complexity and the need of specific Know-How. Xbrane currently possess its own expertise within production of complex generics with slow release formulation and unique technologies for producing proteins efficiently.

http://www.xbrane.com

 

 

 

 

Kommentera

Fyll i dina uppgifter nedan eller klicka på en ikon för att logga in:

WordPress.com Logo

Du kommenterar med ditt WordPress.com-konto. Logga ut / Ändra )

Twitter-bild

Du kommenterar med ditt Twitter-konto. Logga ut / Ändra )

Facebook-foto

Du kommenterar med ditt Facebook-konto. Logga ut / Ändra )

Google+ photo

Du kommenterar med ditt Google+-konto. Logga ut / Ändra )

Ansluter till %s