Regulatory CMC Manager to AstraZeneca
Poolia Sverige AB / Kemistjobb / Stockholm
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hela Sverige Visa alla jobb hos Poolia Sverige AB i Stockholm,
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hela Sverige We are now looking for a Regulatory CMC Manager to a consultant assignment at our customer AstraZeneca in Södertälje. In this role you will support CMC related activities for externalisation projects. Operations Regulatory is a global function that manages all Chemistry, Manufacturing and Controls (CMC) post-approval regulatory activities across AstraZeneca's global supply chain. Do you have a degree in Chemistry, Pharmacy or Chemical Engineering and experience in Regulatory Affairs? Please don't hesitate and submit you CV today!
The role
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.
You will represent Operations Regulatory in externalisation projects and provide input to project switch plans. As part of the role you will also create and review CMC dossiers for transfer to external partners, identify ongoing and upcoming CMC variations and provide Regulatory CMC support for a defined time immediately post MAH transfer.
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.
An understanding of activities needed in support of Marketing Authorisation Transfers is desirable.
Minimum Requirements - Education and Experience
• Degree in Chemistry or Pharmacy or Chemical Engineering
• Fluently spoken and written English and Swedish
• Considerable experience within Pharmaceutical Agencies or Associations or in the Pharmaceutical industry (Regulatory Affairs or Pharmaceutical Production or Quality Assurance or R&D)
• A minimum of 24 months experience in Regulatory Affairs preferably Post Approval Regulatory CMC
Skills and Capabilities
• Project Management skills
• Experience of working within a global environment
• Experience of Marketing Authorisation Transfers
• Able to work collaboratively with customers and colleagues to achieve optimum outcomes
• Ability to work with short and/ or changing timelines
• Attention to details, highly organized, able to plan and control own workload effectively and manage expectation of others
• Experience of working in a LEAN environment
• Excellent written and verbal communication skills
• IT skills and/or knowledge of information and document management technology
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2019-10-18ErsättningFast lön
Så ansöker duSista dag att ansöka är 2019-10-28
Klicka på denna länk för att göra din ansökanFöretagPoolia Sverige AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "54949".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Poolia Sverige AB (org.nr 556426-7655),
http://www.poolia.se Arbetsplats Poolia Life Science & Engineering AB
Jobbnummer 4875646
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