Regulatory CMC Associate Director

Are you a curious scientist with Regulatory experience? Do you want to play a key role in making sure our transformative science born in labs will be transformed into real value for patients? Then this position might be the one for you!

We are now looking to recruit a Regulatory CMC Associate Director with experience of small molecule development to our Regulatory CMC group within Global Regulatory Excellence (GRE) to be based in Gothenburg.

At Regulatory CMC we develop insightful and innovative CMC regulatory approaches to help bring our life-changing treatments to patients across the globe so that no patient waits. We support our development portfolio from early clinical trials through to on market support across a range of therapy areas and modalities. We work in partnerships externally and internally to deliver sound regulatory strategies for all our products.

We are looking for someone who, like us, sees change as an opportunity, embracing the possibility to learn, grow and evolve. This is an exciting opportunity to gain experience of developing innovative regulatory strategies to support a range of new chemical entities and products across multiple therapeutic areas.

What you'll do

As an Associate Director Regulatory CMC you will be part of delivering the CMC regulatory strategy, as well as supporting with operational and tactical expertise for drug development projects from Phase 1 through to global launch. Regulatory CMC Associate Directors are a core member of Global Regulatory Strategy Teams and Pharmaceutical Project Teams and also work closely with colleagues in AZ marketing companies across the globe to ensure successful regulatory approvals for clinical trial and marketing applications. The role also include tasks such as to:

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Provide operational, tactical and some strategic expertise and direction to AstraZeneca project teams, based on understanding of global CMC regulations
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Define the content required for CMC submissions for assigned projects and review and approve regulatory CMC documents (IND, CTA, MAA, NDA, JNDA etc)
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Manage risk using evaluative judgements in complicated or novel situations and provide effective mitigation strategies
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Effectively communicate with cultural sensitivity to achieve successful regulatory outcomes.
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Manage a portfolio of projects for new chemical entities or line extensions and represent the group in cross functional CMC and Regulatory teams
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Contribute to (or lead) regulatory CMC components of business related cross functional projects and contribute to the development of new internal guidance

Essential for the role

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Experienced graduate or PhD in a scientific field, typically chemistry, pharmacy or a biological science
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Experience of authoring or review of regulatory submissions and responses to questions.
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Knowledge and understanding of the science and technology associated with pharmaceutical development and manufacture of small and large molecules
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Experience of working in Regulatory Affairs (with focus on CMC) or other relevant experience in the pharmaceutical industry, for example in Pharmaceutical or Analytical Development



Why AstraZeneca
AstraZeneca is a global, innovation-driven BioPharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious disease. But we're more than one of the world's leading pharmaceutical companies.

At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

What's next?
Are you already imagining yourself joining our team? Good, because we can't wait to hear from you. We welcome you with your application, no later than March 29, 2021.

Find out more

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