CMC Regulatory Affairs Associates

We are seeking 3 CMC Regulatory Affairs Associates for an assignment at AstraZeneca based in Södertälje!

Do you have experience with and an interest in using Document Management systems? Are you highly organized with excellent attention to details? Great! We are looking for CMC Regulatory Affairs Associates to join AstraZeneca´s CMC team focused on divestment related activities located in Södertälje. Apply today!

Purpose, Offer and Benefits

This is a 12-month consulting assignment starting immediately. You will be employed by TNG during this time.

At AstraZeneca, we´re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There´s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

Your Responsibilities

As a CMC Regulatory Affairs Associate you will:

• Generate CMC documentation to support lifecycle submissions and keep business wide electronic systems up to date to maintain regulatory status.
• Support externalisation projects where transfer of CMC documentation to external partners is an important and regular task.
• Work with colleagues and other functions within AstraZeneca as well as external partners to obtain information that supports the generation of regulatory CMC documentation.
• Maintenance and change control management of external partners CMC documentation in AstraZeneca systems.

The Bigger Picture

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 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 Expectations

Minimum Requirements - Education and Experience

• Degree in Chemistry or Pharmacy or Chemical Engineering, 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
• Experience from and interest of using Document Management systems
• 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
• High level understanding of GMP and working in a regulated environment
• High level understanding of CMC Regulatory
• Excellent written and verbal communication skills
• IT software skills