CMC Regulatory Affair Manager

CMC Regulatory Affairs Manager

• AstraZeneca
• Södertälje
• 12-month consultancy assignment

Join us in applying global CMC regulations and guidance within AstraZeneca, while also contributing to the development of new policies and processes.

• Manage the timely preparation (may include authoring) and delivery of CMC contributions to regulatory submissions linked to medicinal products throughout the lifecycle, including clinical programs, marketing authorisation applications, and all post-approval activities.
• Deliver "submission ready" CMC modules to internal and external regulatory stakeholders in compliance with relevant AstraZeneca systems and procedures, ensuring submission quality.
• Ensure that publishing tools are in place and perform publishing of the CMC sections in a timely manner.
• Lead/represent PT&D and Pharm Sci on cross-functional work streams.
• Document maintenance and communication of Health Authority approval status.
• Develop and build expertise in regional regulatory requirements to ensure compliance of CMC submissions.
• Adapt to changing situations to ensure on-time delivery through project management expertise.
• Proactively share learning from own projects with colleagues.
• Act as Subject Matter Expert (SME) or Sub-Process Owner (SPO), contributing to and advising project teams where applicable.
• Provide advice, training, and mentorship to other team members.
• Manage change requests (Veeva), escalate, and input into the cross-functional vote.
• Support the agreed strategy to employ fit-for-purpose content, applying regulatory intelligence to optimise proposed submission content.
• Participate in regulatory execution and delivery meetings, providing relevant updates to the CMC team.
• Contribute to business process optimisation activities to reduce waste and ensure efficiency.
• Continually evolve and develop regulatory expertise through proactive recording and communication of Health Authority interactions, responses, and commitments.
• Apply GxP principles according to the stage of the product lifecycle.
• Responsible for change management as assigned.
• Understand application of appropriate risk management across own activities.
• Demonstrate research skills in understanding regulations and guidance from different regulatory agencies.

• Bachelor's degree in Science or technical field such as pharmacy, biology, chemistry or biological science.
• IT Skills
• Stakeholder & Project management
• Professional capabilities: Regulatory knowledge

• Master's degree in Science or technical field such as pharmacy, biology, chemistry or biological science.
• Direct Regulatory Affairs CMC experience with submissions for Biologic and biotechnology-derived products such as monoclonal antibodies or complex biologic products.
• Knowledge of the drug development process and regulatory submissions
• Understanding of current regulatory CMC requirements
• Understanding of regulations and guidance governing the manufacture of biotechnology products
• Lean capabilities

Start date: 2nd June

At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energised and rewarded for their ideas and creativity.

What you need to do now

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