CMC Regulatory Affairs Associate

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 CMC Regulatory Affairs Associates to our product teams for post approval regulatory management 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.

About the position
As a CMC Regulatory Affairs Associate your main focus will be to generate CMC documentation to support lifecycle submissions and keep business wide electronic systems up to date to maintain regulatory status. You may also support externalisation projects where transfer of CMC documentation to external partners is an important and regular task.

You will work with colleagues and other functions within AstraZeneca to obtain information that supports the generation of regulatory CMC documentation.

Your profile
Minimum Requirements - Education and Experience
• Degree in Chemistry or Pharmacy or Chemical Engineering, minimum 120 p or equivalent experience
• Fluently spoken and written English and Swedish
• Experience in Pharmaceutical Production or Quality Assurance or Quality Control or Product Maintenance or Regulatory Affairs

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

About the organisation
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.