Regulatory CMC Associate, AstraZeneca, Södertälje

Job description
Regulatory CMC Associate, Operations Regulatory
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 looking for Regulatory CMC Associates to our product teams located in Södertälje.  

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.

Responsibilities
The role
As a Regulatory CMC Associate 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.
You will work with colleagues and other functions within AstraZeneca to obtain information that supports the generation of regulatory CMC documentation.

You may also support externalisation projects and transfer of CMC documentation to external partners.

Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.

Qualifications
Minimum Requirements - Education and Experience
• Degree in Chemistry or Pharmacy or Chemical Engineering
• Fluently spoken and written English and Swedish
• Experience in Post Approval Regulatory CMC including CMC documentation authoring
• Experience in Pharmaceutical Production or Quality Assurance or Quality Control or Product Maintenance or Regulatory Affairs

Skills and Capabilities
• Able to work collaboratively with customers and colleagues to achieve optimum outcomes
• Knowledge of information and document management technology
• IT software skills
• Ability to work with short and / or changing timelines
• Attention to details, highly organized, able to plan and control own workload effectively and manage expectation of others
• Excellent written and verbal communication skills
• Experience from using Document Management systems

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. 

Application
Selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.

About the company
Randstad Life Sciences is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus!