Regulatory CMC Manager, Global Quality Supply Chain

Are you an organized person who likes project management 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. Right now, we are looking for two new Regulatory CMC Manager colleagues, one position is permanent and the other is a temporary 12 months secondment in two of our product teams.



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 AZ 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?





The role

The Regulatory CMC Manager provides CMC regulatory and compliance advice on regulatory post-approval submissions and project manages timely submissions of post approval CMC documentation.



As a Regulatory CMC Manager you will generate CMC documentation to support lifecycle submissions and keep business wide electronic systems up to date to maintain regulatory status up to approval of CMC documentation supplied by Operations to Global Regulatory Affairs.



The role expects an understanding of AZ Global Supply Chain 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 expected to use your regulatory knowledge to deliver to high standards, influence others and ensure the application of global CMC regulations and guidance within AstraZeneca.





Minimum Requirements - Education and Experience

* Degree in a scientific discipline (for example, Chemistry, Pharmacy or Chemical Engineering)
* Fluent in spoken and written English and Swedish
* Considerable experience 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



Skills and Capabilities

Your project management skills will come well to use likewise your experience of working within a global environment. The role requires that you can work collaboratively with customers and colleagues to achieve optimum outcomes. You are a person with attention to details, who is highly organized, able to plan and control your own workload effectively and manage expectation of others. We value your experience of working in a LEAN environment and your communication skills which is excellent both written and verbal. You have IT skills and/or knowledge of information and document management technology and electronic/paper publishing software.



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.



Interested?

Please submit your application in English no later than August 25th 2019. 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 Helena Knutsson 070 9154590 or Malin Kvist 070 9154122.



AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.