Global labelling manager within Regulatory Affairs to Sobi
Poolia Stockholm AB / Apotekarjobb / Solna
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hela Sverige Are you a Pharmacist with knowledge about guidelines and regulations for product information and labelling? Are you familiar with artwork programs such as Adobe Illustrator and lnDesign? Sobi is now recruiting to a position as Global labelling manager within Regulatory Affairs to Sobi.
As labelling manager, you will be at part of a competent group supporting in the development and mainte-nance of drug products for our entire organization as it relates to labelling.
The position is full time and based in Stockholm. We will interview candidates continuously and welcome your application today.
Job description
As Global labelling manager you will be a part of the Product Information group within the Regulatory Affairs department. Your responsibility will be to give professional regulatory support in the development and maintenance of drug products for our entire organization as it relates to labelling. You will ensure that the Product Information group and the whole Regulatory Affairs department are recognized as professional partners and to develop and maintain artwork and product information for Sobi MAH products. You will deliv-er on time and with the right quality.
As Global labelling manager, your responsibilities will include:
• Being the labelling representative in the Product Supply team
• Planning, creation and maintenance of artwork for Sobi MAH products
• Coordination of proofreading of artwork for Sobi MAH products
• Being the labelling expert and contact person to internal functions as well as external stakeholders as it relates to labelling
• Follow up on relevant guidelines as required
• Publishing of approved product information and artwork on Inside
• Performing QC check of product information, especially within the linguistic review process for EU centralized procedure.
• As a member of the Product Information team, participate in our continuous work to improve our processes and best practices
• Develop and update SOPs related to processes under the scope of the Product Information team.
Qualifications
Key qualifications are:
• University degree within Life Science preferably pharmacist.
• Familiar with artwork programs such as Adobe Illustrator and lnDesign.
• Desired: Experience from pharmaceutical industry or competent authority and from working with product information and labelling.
• It is a merit if you have knowledge about guidelines and regulations for product information and labelling.
• Excellent verbal and written communication skills in English and preferably also in Swedish.
To be successful in this role you need to be organized, thorough with an eye for details. You like working to-wards deadlines and have a professional, flexible, service-minded approach to your work. The suitable candidate should demonstrate the Sobi Values; Care for our patients, for our colleagues and for our company, Ambition, Urgency, Ownership and Partnership.
Swedish Orphan Biovitrum AB
Sobi is an international raredisease company dedicated to making a significant difference for individuals with rare diseases by providing access to innovative treatments. Our Vision is to be recognized as a global leader in providing access to innovative treatments that make a significant difference for individuals with rare diseases. The product portfolio is primarily focused on Haemophilia, Inflammation and Genetic diseases. Sobi also markets a portfolio of specialty and rare disease products across Europe, the Middle East, North Africa and Russia for partner companies. Sobi is a pioneer in biotechnology with world-class capabilities in protein biochemistry and biologics manufacturing. In 2017 Sobi had total revenues of SEK 6.5 billion and about 780 employees. The share (STO: SOBI) is listed on Nasdaq Stockholm. More information is available at
www.sobi.com.Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2018-12-19ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2019-01-20
Ange följande referens när du ansöker: 52220
Klicka på denna länk för att göra din ansökanFöretagPoolia Stockholm AB
AdressPoolia Stockholm AB
Kungsgatan 57 A
10124 Stockholm
KontorsadressKungsgatan 57 A
Jobbnummer 4520287
Observera att sista ansökningsdag har passerat.