CMC Regulatory Affairs Associate at AstraZeneca

Are you seeking a new opportunity? AstraZeneca in Södertälje is seeking a CMC Regulatory Affairs. Apply today!

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 join one of our CMC teams focused on biologics products at AstraZeneca in Södertälje!

Purpose, Offer and Benefits

 This is a 1-year consulting assignment starting in early December. You will be employed by TNG during the assignment.

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.

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.

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

The Bigger Picture

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because an opportunity no matter how small can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential.

Our Expectations

• 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

Skills and Capabilities

• 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