Global Labelling / Regulatory Affairs Manager for AstraZeneca
AstraZeneca / Proffice Link AB / Apotekarjobb / Mölndal
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hela Sverige For AstraZeneca we are now looking for a Global Labelling Operations Manager in the arena of Regulatory Affairs.
The consultant assignment will start immediately and go on for 12 months will good possibilities for extension.
Interviews and selections are held on an ongoing basis so please apply today!
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. AstraZeneca is proud to offer a unique workplace culture that inspires innovation and collaboration. Co-workers are empowered to express diverse perspectives and are made to feel valued, energized and rewarded for their ideas and creativity
Publiceringsdatum2016-02-18Dina arbetsuppgifterThe Global Labeling Group is part of Global Regulatory Affairs and focuses on both the preparation and maintenance of labelling documents for prescribing information, patient information and regulatory information on packages for Health Authority approval. They are currently working on products for the EU and US markets. The group is now looking for two Labeling Operations/Associate Directors, on a temporary basis, who are responsible for the regulatory role as part of the labeling process, each dealing with one aspect of GLG responsibilities, please see below.
• In the document management role, the focus will be to deal with preparation and formatting of labeling documents for submissions to Health Authorities, file managing and archiving in designated databases, translation preparation and process (linguistic review within EU).
• In the packaging and artwork role, the focus will, include creation of the printed material for products under development, updating of existing artworks for already marketed products, liaising with Marketing Companies in Europe as well as packaging sites within production.
Your main tasks will be:
• Point of contact for Regulatory Affairs towards the process for the creation, approval, and implementation of commercial printed labeling in collaboration with various functions
• Coordinate and/or lead cross-functional teams in the development and lifetime maintenance of the US, EU and other regional packaging component labeling for all commercial products
• Provide tactical and strategic guidance to product labeling teams regarding placement and regulatory requirements for regional packaging component labeling content and design
• Manage labeling submissions for US and EU, including Quality Check, proofing, copy editing and formatting of documents, and coordinate review and approval of final submission
• Interpret regional labeling regulations and guidance, determining company impact and providing comments as appropriate
• Interact with Marketing Company colleagues regarding global artworks as appropriate
• Maintain repository of current labeling documents
• Process and prepare all US Final Printed Labeling and required EU specimens for submission
• Assist Global Labeling team in resolution of labeling issues as needed
• Participate in the development and maintenance of work practices, templates, and associated documents relating to the labeling function
• Assist in other regulatory activities as required
Utbildning/erfarenhet
You hold a University Degree in Science or related discipline and have 3 to 5 years pharmaceutical experience, preferably regulatory experience, preferably working with labeling. You additionally have knowledge of labeling regulations and guidances.
You have keen attention to detail and accuracy, excellent verbal and written communication skills in English is necessary. Good skills in verbal an written Swedish is appreciated but is not a requirement. Experience in packaging labeling development is highly appreciated but is not a requirement.
You have the ability to work collaboratively building Relationships, have good negotiation skills (good listener; able to build a consensus), are critical Information Seeking, have rational persuasion and interpersonal Awareness. additionally you have Multi-cultural awareness and sensitivity, demonstrated experience effectively communicating and negotiating in diverse cultures, ability to think strategically, appropriately assess risks and formulate strategies to manage risk.
Varaktighet, arbetstid
100 Visstidsanställning
ErsättningMånadslön
Så ansöker duSista dag att ansöka är 2016-03-02
Ange följande referens när du ansöker: 661124
Klicka på denna länk för att göra din ansökanFöretagAstraZeneca / Proffice Link AB
AdressAstraZeneca / Proffice Link AB
Kungsgatan 57 A, Box 207
10124 Stockholm
KontorsadressKungsgatan 57 A, Box 207
Jobbnummer 2678954
Observera att sista ansökningsdag har passerat.