CMC Regulatory Affairs Manager

Do you like working cross-functionally in a global environment and have experience from pharma industry? Maybe you've also worked with Regulatory CMC submissions and/or product maintenance? Then you're the one we're looking for!

At Campus Södertälje, we come together in an innovative and high-tech environment to manufacture life-changing medicines. Here we enjoy days filled with healthy choices: from morning workouts in the training room, laughter-filled coffee breaks with colleagues, or walks on the Campus nature trail. Welcome to our world, where we have 42 different nationalities, half of our leaders are women, and we all work actively for a healthier world for our employees and our patients: For us, where there is a drive, there are opportunities. Which path do you choose?

CMC Regulatory Affairs is a global function that manages all Chemistry, Manufacturing and Controls (CMC) regulatory activities across AstraZeneca's global supply chain.

We are looking for a CMC Regulatory Affairs Manager to join our CMC team to support post-approval CMC variations across the globe.

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. Join us and be part of an extraordinary place to work; an environment that energizes and empowers each of us to support compliant product supply through partnership with other AstraZeneca teams.

What you'll do
As our CMC Regulatory Affairs Manager you will provide CMC regulatory and compliance advice on regulatory post-approval submissions and project manage timely submissions of post approval CMC documentation.

Our new colleague is expected to have broad knowledge of medicinal products, project management, pharmaceutical process engineering, complex Supply Chains in global organisations, and how you contribute to achieving the objectives of the business as well as an understanding of the teams and organisation you interact with. The role offers you opportunities to work with global networks.

You will be encouraged to use your regulatory knowledge to deliver to high standards, influence others and ensure the application of global CMC regulations and guidance within AstraZeneca.

Essential for the role
You hold a degree in a scientific field (for example, Chemistry, Pharmacy or Chemical Engineering).

In addition, you need:

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Experience from CMC Regulatory affairs or Regulatory Affairs
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Experience from working in the Pharmaceutical industry, preferably Pharmaceutical Production, Process Engineering, Quality Assurance or R&D, or experience from Pharmaceutical Agencies or Associations
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Practice from working with or contributing to Regulatory CMC submissions including for medical products
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Project management experience, preferably within CMC Regulatory Affairs
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To be proficient in spoken and written English

Desirable for the role

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You have excellent communication skills
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You can build constructive networks with colleagues and work collaboratively with customers to achieve optimum outcomes for the business.
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Strong project management skills and experience of working within a global environment will be invaluable for planning and controlling your own workload as well as effectively managing the expectations of diverse stakeholders.
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You are comfortable with the use of electronic information and document management tools, and standard Office programs

The position can sit at our locations in Gärtuna or Gothenburg, Sweden or Macclesfield, UK.

So, what's next?
Are you already imagining yourself joining our team? Great, because we can't wait to hear from you.

Please submit your application in English, no later than 22 November 2022.

Interviews will be held during the advertisement period so don't hesitate to apply!

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn

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Date Posted

2022-11-07

Closing Date

2022-11-22

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.

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