Regulatory CMC Director- Small Molecules Inhalation

AstraZeneca / Apotekarjobb / Göteborg
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At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing.

Respiratory disease is one of AstraZeneca's main therapy areas, and the company has a growing portfolio of medicines that reached more than 18 million patients in 2016.

AstraZeneca's aim is to transform asthma and COPD treatment through inhaled combinations at the core of care, biologics for the unmet needs of specific patient populations, and scientific advancements in disease modification.

The Arena

The Regulatory Chemistry, Manufacturing and Control (CMC) group sit within the AZ Global Regulatory Affairs, Patient Safety and QA (GRAPSQA) organisation and 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 CMC Director for small molecules with experience of inhalation of small molecules and possibly inhalation of new modalities to join our team in Gothenburg, Gaithersburg or Macclesfield.

As Regulatory CMC Director, you will manage complex projects for new chemical entities or line extensions as a representative of Regulatory CMC. You will also be expected to lead and/or deliver regulatory CMC components of business related projects across functions, as well as providing operational, tactical and strategic regulatory CMC expertise and direction to AstraZeneca project teams.

Minimum Requirements

* Experienced graduate or PhD in a scientific discipline, typically chemistry, pharmacy or a biological science.
* A significant knowledge and understanding of the science and technology associated with pharmaceutical development and manufacture of small molecules.
* Proven experience in Regulatory Affairs, with focus on CMC or other relevant experience in the pharmaceutical industry, for example in Pharmaceutical or Analytical Development, Quality Control, Manufacture.
* Has successfully contributed to at least one major regulatory submission in the global environment.
* Significant project or line management experience in a relevant environment.
* Significant experience of health authority requirements for inhalation formulations for small molecules and possibly inhalation of new modalities.

For more information, please visit our websites:

Gothenburg site: https://www.astrazeneca.com/our-science/gothenburg.html

Gaithersburg site: https://www.astrazeneca.com/our-science/gaithersburg.html

Macclesfield site: https://www.astrazeneca.co.uk/about-us.html

If you are interested, apply now!

For more information about the position please contact Per Niklasson at

Welcome with your application no later than March 21, 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

Publiceringsdatum
2018-03-05

Ersättning
Not Specified

Så ansöker du
Sista dag att ansöka är 2018-03-15
Ange följande referens när du ansöker: R-022619
Klicka på denna länk för att göra din ansökan

Kontakt
AstraZeneca asa.lothigius@astrazeneca.com

Företag
AstraZeneca

Adress
AstraZeneca
43183
43183 1480

Kontorsadress
Pepparedsleden 1

Jobbnummer
4001896

Observera att sista ansökningsdag har passerat.

Regulatory CMC Director- Small Molecules Inhalation

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