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.
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.
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