Regulatory CMC for Astra Zeneca
Alten Sverige AB / Administratörsjobb (offentlig verksamhet) / Stockholm
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hela Sverige About AstraZeneca
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
• 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.
About ALTEN
For over 20 years, ALTEN has developed its business by keeping to the core values that have built up the company's success. Every year, hundreds of ALTEN consultants have been given the opportunity to embark on challenging technical projects for our customers. ALTEN has a tradition of developing products in many areas, and history in Sweden is based primarily on skills in mechanics, software and electronics. Thanks to a successful concept in which we utilize the expertise of experienced consultants and develop young abilities towards a successful career, we have gained ground in many industries. Our Pharma initiative is based on the same successful concept with the same strong structure, but in a new exciting industry and a new field of expertise that includes knowledge in chemistry, biotechnology and biomedicine.
As an employee at ALTEN, we offer you a competitive salary based on your performance and work experience. You also have the opportunity to influence your assignments, different benefits and your overall working environment as well as choose your career path. We offer a wide range of internal trainings and an opportunity to plan for an international career. It is our conviction that genuine commitment is created through choice and the ability to influence your own personal development - our business model provides that opportunity. This freedom of choice enables us to offer our clients the most committed consultants, regardless of assignments. At ALTEN, we believe in growing together!
For questions about the position, please contact Fanny Chantereau, Business Manager Pharma, at
fanny.chantereau@alten.seVaraktighet, arbetstid
Heltid Tillsvidareanställning
Publiceringsdatum2019-01-08ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2019-01-20
Klicka på denna länk för att göra din ansökanKontaktHR-avdelningen, Alten
FöretagAlten Sverige AB
AdressAlten Sverige AB
Theres Svenssons gata 15
41755 Göteborg
KontorsadressTheres Svenssons gata 15, Göteborg
Jobbnummer 4542374
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