Do you feel passionate about the possibilities of science to change lives?

At AstraZeneca, we’re not afraid to do things differently. We’re resetting expectations of what a bio-pharmaceutical company can be. This means we are opening up new ways to work, ground-breaking methods and bringing excellent teams together.

Our purpose is ambitious and so is our approach. Becoming a more agile and innovative company means building a dynamic, inspiring culture where we celebrate forward thinking and act with a sense of urgency. We are ambitious, taking risks and learning from both success and failure. We are curious, creative, and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Are you ready to move forward in your career? Join us and be part of an outstanding place to work; an environment that energizes and empowers each of us to achieve our goals!

We are looking for a Regulatory Chemistry, Manufacturing and Controls Director to join us on a permanent basis in either the UK, Sweden or US.

Main Responsibilities

• Proactively lead complex projects for new biologic or other modality, or line extensions and post approval submissions, as a representative of Regulatory CMC, helping to build innovative, risk based Regulatory strategies. Will lead and/or deliver regulatory CMC components of business related projects across functions.
• Provide progressive strategic, tactical or operational, regulatory CMC expertise and direction to AstraZeneca Global project teams
• Establish effective networks with marketing companies, manufacturing sites and relevant technical functions such as Development, Operations or Quality as appropriate for assigned projects. May act as key contact for identified customer functions to facilitate high quality partnerships.
• Lead high level risk by looking at regulatory options and making complex judgements, developing innovative risk based solutions and applying progressive comprehensive cross-functional and industry understanding
• Ensure the awareness of global CMC regulations and guidance exists within AstraZeneca, to enable development of scientific and regulatory strategies to negotiate with Agencies and develop fit for purpose global submissions.

Key Skills

• 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, and aware of advances in Agency thinking in these areas.
• Experienced in Regulatory Affairs, with focus on CMC. Other relevant experience in the pharmaceutical industry, for example in Pharmaceutical or Analytical Development, Quality Control, Manufacture, might also be considered.
• Previously contributed to at least one major regulatory submission in the global environment.
• Significant project or line management experience in a relevant environment.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.