We're looking for a Regulatory Affairs Manager - AstraZeneca - AstraZeneca AB - Kemistjobb i Södertälje
We're looking for a Regulatory Affairs Manager - AstraZeneca
AstraZeneca AB / Kemistjobb / Södertälje
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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 are looking for!

Operations Regulatory is a global function that manages all Chemistry, Manufacturing and Controls (CMC) post-approval 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.

Our offices are located in Södertälje and here we welcome you to AstraZeneca's "production heart", one of the world's largest manufacturing units for pharmaceuticals. We thrive in a high-tech and LEAN-based environment where we put a high value on collaboration and smart solutions. Our two sites are located close to urban environments as well as the waterfront and forests. Why not start the day in our gym or end the day with your colleagues in a spinning class?

Main duties and responsibilities

Our Regulatory CMC 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 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 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 Requirements - Education and Experience

We would like you to hold a degree in a scientific discipline (for example, Chemistry, Pharmacy or Chemical Engineering). In addition to this you need:

* experience from working in the Pharmaceutical industry (Regulatory Affairs or Pharmaceutical Production or Quality Assurance or R&D) or within Pharmaceutical Agencies or Associations.
* experience of working with or contributing to Regulatory CMC submissions
* to be proficient in both spoken and written English and Swedish.

Desirable requirements

You have excellent communication skills, can readily build constructive networks with colleagues and work collaboratively with customers to achieve optimum outcomes for the business. Your 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. You are comfortable with the use of electronic information and document management tools, and standard Office programs. And not least, experience of working in a LEAN environment would be advantageous.

Why AstraZeneca?

When we see the chance to change, we take this opportunity - for every opportunity, no matter how small, can be the beginning of something big. Delivering medicine that changes people's lives is about having an entrepreneurial spirit - finding moments and understanding its potential.

We are looking for you, who together with your team will make a difference for patients' lives every day. This through your ability to lead and motivate your collaborators and colleagues to achieve set goals on time and at the right quality. We at AstraZeneca welcome your positive attitude and your desire to develop both yourself, your team and the department.

Are you already imagining yourself joining our team in Södertälje? Great, because we can't wait to hear from you.

Please submit your application in English no later than February 9th 2020. Interviews will be held continuously, so don't hesitate, apply now! We look forward to hearing from you.

For further information regarding this role please contact David Brown: David.

Varaktighet, arbetstid
Heltid Permanent


Not Specified

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Sista dag att ansöka är 2020-02-10
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Astrazeneca AB


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