Head of CMC Regulatory Affairs within Biologics, Xbrane
Search4S Dustgoat AB / Övriga jobb / Solna
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hela Sverige 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.
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!
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.
Varaktighet, arbetstid
The employment is with Xbrane. It is not a Consultant assignment.
Publiceringsdatum2017-02-01Så ansöker duSista dag att ansöka är 2017-02-26
Ange följande referens när du ansöker: Xbrane CMC
KontaktAnna Rennermalm
anna@search4s.se +46707942005
FöretagSearch4S Dustgoat AB
AdressSearch4S Dustgoat AB
Banvaktsvägen 22
17148 Solna
KontorsadressBanvaktsvägen 22
Jobbnummer 3294836
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