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Regulatory CMC Manager, Operations Regulatory, Global Supply Chain Quality
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 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
- 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.
Job type: Full time
Deadline for applications: 2019-01-24
More information: Sofie Önnestam, firstname.lastname@example.org, 073 343 99 61
Please send your application in English.
We encourage you to send your application as soon as possible, since interviews and candidate selection are done continuously! We put great emphasis on personal suitability for this role.
Dfind Science & Engineering is part of Randstad, one of the Nordic region's largest specialists within staffing, recruitment and outplacement.
Dfind Science& Engineering is specialized in recruitment and consulting providing competences within Life Science, Science and Engineering and is a company where people make all the difference. At Dfind Science & Engineering specialists are recruiting specialists!
All our recruitment consultants , consultants and sourcing managers have a technical or scientific background, combined with extensive networks within relevant communities and expertise within recruitment and HR. We understand our customers specific requirements and know how to find the best candidates. Through our passionate commitment and high degree of attentiveness we help people and businesses to grow and be competitive in a changing world.