Regulatory CMC Manager
AstraZeneca Södertälje / Kemistjobb / Södertälje
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hela Sverige As an innovation-driven biopharmaceutical business, AstraZeneca is making a genuine difference to healthcare around the globe with patients need at the heart of everything we do. A truly global company, we are active in over 100 countries and have a growing presence in emerging markets such as China, Brazil, India and Russia. For all our people, we offer challenging and rewarding opportunities across a wide range of specialist disciplines.
The arena
The role of Regulatory CMC Manager is focused on Post Approval Regulatory Chemistry, Manufacturing and Control (CMC) strategy and delivery within our CMC Regulatory Compliance Department. CMC Regulatory Compliance is part of the Global Operations Quality function.
The role
Main purpose of the role:
To produce and manage the production of CMC documentation for designated commercial products at various stages of product life-cycle, in the required format and to the agreed timetable. To ensure that key stakeholders are kept informed of relevant timelines and regulatory commitments for those products. To work as a partner within relevant product and project teams providing regulatory intelligence and advice, and strategic input, as appropriate
This role is available as permanent contract and will be based in Södertälje, Sweden.
Accountabilities/Responsibilities:
The Regulatory CMC Manager provides CMC regulatory and compliance advice on regulatory post-approval submissions and project manages timely submissions of post approval CMC documentation.
As a Regulatory CMC Manager you will generate CMC documentation to support lifecycle submissions and keep business wide electronic systems up to date to maintain regulatory status up to approval of CMC documentation supplied by Operations to Global Regulatory Affairs.
As Regulatory CMC Manager you will be expected to use your regulatory knowledge to deliver to high standards, influence others and ensure the application of global CMC regulations and guidance within AstraZeneca.
The role expects an understanding of the Operations Function and how it contributes to achieving the objectives of the business as well as an understanding of the functions it interacts with. The role offers opportunities to work with global networks.
Minimum Requirements - Education and Experience
Essential requirements:
Degree, or equivalent, in Chemistry or Pharmacy or Chemical Engineering
Considerable experience in the Pharmaceutical industry, for example Pharmaceutical Production or Regulatory Affairs or Quality Assurance and R&D
Fluently spoken and written English and Swedish
Project Management skills
Experience of working within a global environment
Team working skills, Flexibility, Adaptability, Influencing, Initiative
Preferable requirements:
Previous experience of working in a regulatory CMC environment
Experience of working with international markets
Experience of working in a LEAN environment
Excellent written and verbal communication skills
IT skills and/or knowledge of information and document management technology and electronic/paper publishing software
More information
For further information regarding this role please contact Mauro de Sario at +46 8 553 21207 or Karin Grosch at +46 8 552 540 98.
Please submit your application in English no later than January 31st.
Applications will be reviewed continuously. Interviews are planned for w/c February 8th.
TO APPLY, please visit
www.astrazeneca.comVaraktighet, arbetstid
Tillsvidare
Heltid
Publiceringsdatum2016-01-15ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2016-01-31
Ange följande referens när du ansöker: SOD000002C7
FöretagAstraZeneca Södertälje
AdressAstraZeneca Södertälje
Västra Mälarhamnen 9
15185 Södertälje
Övriga kontaktuppgifterTelefonnummer: 08-553 260 00
Jobbnummer 2618338
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