CMC Regulatory Affairs Manager

Global CMC Regulatory team

Hays Life Sciences is now looking to recruit a CMC Regulatory Affairs Manager to join the Global CMC Regulatory team for a 1-year contract assignment at AstraZeneca in Södertälje.

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 in Södertälje 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 a 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 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
You 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 for 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.
* You 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 stakeholders.
* You are comfortable with the use of electronic information and document management tools