Regulatory CMC Associate Director - Small Molecules
AstraZeneca / Apotekarjobb / Göteborg
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hela Sverige At AstraZeneca we are guided in our work by a strong set of values, and we're resetting expectations of what a bio-pharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring unexpected teams together. From scientists to sales, lab techs to legal, we're on a mission to turn ideas into life-changing medicines that transform lives.
We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world. If you're swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.
Description
The Regulatory CMC (Chemistry, Manufacturing and Control) groups sit within the AZ Global Regulatory Affairs, Patient Safety and QA (GRAPSQA) organisation. Regulatory CMC is accountable for delivering CMC regulatory strategy as well as operational and tactical expertise for drug development projects from Phase 1 through to global launch.
Regulatory CMC is a key member of Pharmaceutical Development Project Teams and Global Regulatory Project Teams and works with colleagues in the local marketing companies to ensure successful regulatory approval for clinical and marketing submissions.
We are now looking to recruit a Reg CMC Associate Director to join our team in Gothenburg, Sweden.
As Regulatory CMC Associate Director you will manage development projects for new chemical entities and line extensions for small molecules.
You will
* Define the content of CMC submissions and review and approve regulatory CMC documents on behalf of GRAPSQA. The most common submissions are clinical trial applications, marketing authorization applications and line extensions across a range of markets.
* Provide operational, tactical and increasingly strategic regulatory CMC expertise and direction to AstraZeneca project teams.
* Prepare and support Health Authority meetings, across a range of markets.
* Manage risk using evaluative judgements in complicated or novel situations.
* Ensure the application of global CMC regulations and guidelines and will contribute to development of new guidelines.
* Use effective levels of interactive communication within the project team and directly advising and influencing those within the team.
* Participate in knowledge sharing within Regulatory CMC.
You will also be expected to contribute to and may lead regulatory CMC components of business related projects across functions
Minimum Requirements
* Experienced graduate or PhD in a scientific discipline, typically chemistry, pharmacy or a biological science.
* Several years proven experience in Regulatory Affairs and CMC.
* Relevant experience in the pharmaceutical industry, for example in Pharmaceutical or Analytical Development, Quality Control and Manufacture.
* Regulatory submissions experience.
* A significant knowledge and understanding of the science and technology associated with pharmaceutical development and manufacture of small molecules.
If you are interested, please apply now!
Welcome with your application no later than October 19th, 2018.
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 country/ies where the role is advertised.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2018-09-21ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2018-10-10
Ange följande referens när du ansöker: R-022621
Klicka på denna länk för att göra din ansökanKontaktAstraZeneca
jessica.tangefjord@astrazeneca.comFöretagAstraZeneca
AdressAstraZeneca
43183
43183 1480
KontorsadressPepparredsleden 1
Jobbnummer 4361908
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