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Regulatory CMC Associate Director - Small Molecules

Posted 12 February by AstraZeneca Featured Ended

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.

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 Reg CMC Associate Director to join our team in Gothenburg, Sweden or Macclesfield, UK. 

As Regulatory CMC Associate Director you will manage projects for new chemical entities or line extensions as a representative of Regulatory CMC. You will also be expected to contribute to and may lead regulatory CMC components of business related projects across functions, as well as providing operational, tactical and increasingly 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. Other relevant experience in the pharmaceutical industry, for example in Pharmaceutical or Analytical Development, Quality Control, Manufacture, will also be considered.
  • Has successfully contributed to regulatory submissions.

For more information, please visit our websites:

Gothenburg site:

Macclesfield site:

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 7, 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.

Reference: 34457666

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