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!

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

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 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
Our CMC Regulatory Affairs Managers 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 organizations, and how you contribute to achieving the objectives of the business as well as an understanding of the teams and organization 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
We would like you to hold a degree in a scientific field (for example, Chemistry, Pharmacy or Chemical Engineering). In addition, you need:
• Experience from CMC Regulatory affairs or Regulatory Affairs
• Experience from working in the Pharmaceutical industry preferably Pharmaceutical Production, Process Engineering, Quality Assurance or R&D, or experience from Pharmaceutical Agencies or Associations
• Practice from working with or contributing to Regulatory CMC submissions including medical products
• Project management experience, preferably within CMC Regulatory affairs
• To be proficient in both spoken and written English and Swedish

Desirable for the role
You have excellent communication skills, can build constructive networks with colleagues and work collaboratively with customers to achieve optimum outcomes for the business. 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 partners. You are comfortable with the use of electronic information and document management tools, and standard Office programs. Background from a LEAN environment would be advantageous.

Why AstraZeneca?
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, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

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


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