Regulatory CMC Manager to AstraZeneca Södertälje
Modis Sweden AB / Läkarjobb / Södertälje
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hela Sverige Modis is a staffing & recruiting company and is part of the Adecco Group, the world 's leading HR-solutions provider across 60 countries. This scale and scope ensures Modis is truly a global community. Our mission is to be the Leading Professional Services Company by finding the right match between you as a candidate and you as a customer. We are a team with various and complementary backgrounds within Life Science, Engineering and Technology. We can ensure that we understand our customer needs and we can ensure that we understand the competence-profiles of our applicants and candidates.
We are now seeking for a Regulatory CMC Manager to AstraZeneca in Södertälje (within Operations Regulatory, Global Supply Chain Quality.)
About the customer
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world 's most serious diseases. But we 're more than one of the world 's leading pharmaceutical companies. At AstraZeneca, we 're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.
Operations Regulatory is a global function that manages all Chemistry, Manufacturing and Controls (CMC) post-approval regulatory activities across AstraZeneca 's global supply chain.
We are now looking for a Regulatory CMC Manager to support CMC related activities for externalisation projects.
This role is available as a temporary contract and will be based in Södertälje, Sweden.
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
* Experience of working in a LEAN environment
* Excellent written and verbal communication skills
* IT skills and/or knowledge of information and document management technology.
* 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
Please submit your application in English today, or by latest 2019-01-20 by attaching your CV and personal letter (interviews are held continuously).
If you have any questions about the assignment, do not hesitate and contact Markus Dahl (
markus.dahl@modis.se).
Varaktighet, arbetstid
Heltid Full time (40h/week)
Publiceringsdatum2019-01-03ErsättningFast lön
Så ansöker duSista dag att ansöka är 2019-01-20
Klicka på denna länk för att göra din ansökanKontaktMarkus Dahl
FöretagModis Sweden AB
AdressModis Sweden AB
Hamngatan 13
11146 Stockholm
KontorsadressHamngatan 13
Jobbnummer 4535559
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