Regulatory CMC Manager, Operations Regulatory to AstraZeneca
Alten Sverige AB / Biomedicinjobb / 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
What we offer you at ALTEN
Every employee is equally valuable in the success of ALTEN! We are driven by making people grow and develop, which is why we offer you the opportunity to work with what you are truly passionate about. At ALTEN, we have a broad range of assignments at most of the leading companies in Sweden in several different sectors, to make it possible for your wishes to come true. We offer both national and international opportunities and together with your coaching manager, you build your career path so you constantly are able to develop and achieve your goals and dreams!
As a consultant at ALTEN, you will get the genuine team feeling at your assignment but also a wonderful togetherness at ALTEN. Through our different internal networks, such as ALTEN Sports, Women@ALTEN and ALTEN Innovation you will get the opportunity to drive topics and activities that are close to your heart, together with your colleagues. All activities are of course optional. Work life balance is our top priority. We also have a collective agreement and other benefits like Pension, Insurances and Wellness grants.
We believe in growing together!
Varaktighet, arbetstid
Heltid Tillsvidareanställning
Publiceringsdatum2019-10-18ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2019-11-01
Klicka på denna länk för att göra din ansökanFöretagAlten Sverige AB
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Alten Sverige AB (org.nr 556420-7453)
Jobbnummer 4855617
Observera att sista ansökningsdag har passerat.