Regulatory Affairs Manager
Modis Sweden AB / Läkarjobb / Södertälje
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hela Sverige Modis Life Science is looking for a Regulatory CMC Manager
to AstraZeneca in Södertälje!
The Consultant assignment will start as soon as possible and proceed until 2018-12-31.
Welcome with your application no later than 2018-04-12!
Regulatory CMC Manager
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 are 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.
CMC Regulatory Compliance & Stability is a global function that manages all Chemistry, Manufacturing and Controls (CMC) post-approval regulatory activities across the global supply chain.
The role
The role of Regulatory CMC Manager is focused on Post Approval Regulatory Chemistry, Manufacturing and Control (CMC) strategy and delivery within our CMC Regulatory Compliance Department.
Main Purpose of the role:
To produce and manage the production of CMC documentation for designated commercial products at various stages of product life-cycle, in the required format and to the agreed timetable. To ensure that key stakeholders are kept informed of relevant timelines and regulatory commitments for those products. To work as a partner within relevant product and project teams providing regulatory intelligence and advice, and strategic input, as appropriate
This role will be based in Södertälje, Sweden.
Accountabilities/Responsibilities
• 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.
• As Regulatory CMC Manager 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.
• The role offers opportunities to work with global networks.
Education and Experience
Essential requirements:
• Degree, or equivalent, in Chemistry or Pharmacy or Chemical Engineering
• Considerable experience in the Pharmaceutical industry, for example Pharmaceutical Production or Regulatory Affairs or Quality Assurance and R&D.
• Fluently spoken and written English and Swedish
• Project Management skills
• Excellent written and verbal communication skills
• Experience of working within a global environment.
• Team working skills, Flexibility, Adaptability, Influencing, Initiative
• Previous experience of working in a Regulatory CMC environment.
Preferable requirements:
• Experience of working with international markets.
• Experience of working in a LEAN environment.
• IT skills and/or knowledge of information and document management technology and electronic/paper publishing software
About Modis
We are constantly striving to support our customers and consultants to become successful. As a consultant, you are our top priority and when you need us, we will be there for you.
We will include you in our business and to our customers. You are our most important asset and for us to stay ahead you will take an active part in our business development and our offers to the market.
By becoming our colleague, your daily life as a consultant will be shifting with different assignments and projects in a variety of industries, systems and environments. Your experience will increase as well as your social and professional network. As a consultant, you are covered by collective agreements, insurance, occupational healthcare, healthcare and discounts on training cards. We believe in connecting people so having regularly social activities is key for us.
Modis delivers a wide range of services and competencies within IT, Engineering and Life Science. Our services are characterized by speed, simplicity and quality. Modis is represented in the United States, Canada, Europe with over 100 offices and with more than 35,000 colleagues on assignments each day.
Are you interested?
Then you should apply as soon as possible. The position is soon to be filled and therefore work with recruitment is being done on a continual basis.
If you have questions regarding the position please contact:
Anneli Bermbeck
anneli.bermbeck@modis.se 073 684 83 33
Anders Olsson
anders.olsson@modis.se 073 684 72 48
We look forward to your application!
Varaktighet, arbetstid
Heltid Visstid
Publiceringsdatum2018-03-27ErsättningFast lön
Så ansöker duSista dag att ansöka är 2018-04-13
Klicka på denna länk för att göra din ansökanKontaktAnneli Bermbeck
Anders Olsson Anders.Olsson@Modis.se
FöretagModis Sweden AB
AdressModis Sweden AB
Hamngatan 13
11146 Stockholm
KontorsadressHamngatan 13
Jobbnummer 4047648
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