Regulatory CMC Manager

1 platser Tillsvidare Heltid Not Specified Heltid Permanent

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.

CMC Regulatory Compliance & Stability is a global function that manages all Chemistry, Manufacturing and Controls (CMC) post-approval regulatory activities across AstraZeneca's global supply chain.

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.

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.

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.

This role is available as a permanent contract and will be based in Södertälje, Sweden.

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
* 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 and electronic/paper publishing software

More information
For further information regarding the position please contact Gunilla Jonsson 08-552 55789.

Please submit your application in English no later than June 3rd 2018.

Interviews will be held on ongoing basis.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the countries where the role is advertised.

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> Sista ansökningsdatum: 22 May 2018
Ange referens: R-028054



Pepparedsleden 1


0181, 43183

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