CMC-RA Manager I

Job Title: CMC RA Manager I Submission Excellence & Project Management
Introduction to role:
Are you ready to make a significant impact in the world of Oncology As a CMC RA Manager I, you will effectively manage the production of Chemistry, Manufacturing, and Control (CMC) documentation for designated product ranges, ensuring the needs of both AstraZeneca and our customers are met. You will lead global CMC regulatory submissions, ensuring project activities and documentation meet required standards throughout the product lifecycle. Your role will involve contributing to and leading regulatory CMC components of business-related projects, maintaining effective communication with customers and project team members to ensure timelines and regulatory commitments are met. Youll also apply global CMC regulations and guidance within AstraZeneca, contributing to the development of new guidance, policy, and processes.
Accountabilities:

• Run the timely preparation and delivery of CMC contributions to regulatory submissions linked to medicinal products throughout their lifecycle.
• Deliver submission ready CMC modules to internal and external regulatory collaborators, ensuring compliance with AstraZeneca systems and procedures.
• Document maintenance and communication of Health Authority approval status.
• Develop expertise in regional regulatory requirements to ensure compliance of CMC submissions.
• Adapt project management expertise to changing situations for on-time delivery.
• Share learnings from projects with colleagues and within functions.
• Support strategy to employ fit-for-purpose content using regulatory intelligence.
  
• Participate in regulatory execution meetings and provide updates to the CMC team.
• Chip in to business process optimization activities for efficiency.
• Evolve regulatory expertise through proactive communication of Health Authority interactions.
• Apply GxP principles according to the product lifecycle stage.
• Lead change as assigned and understand risk management across activities.
• Conduct activities consistent with Things We Value and compliance with the Code of Ethics.
  

Essential Skills/Experience:

• University degree in a science or technical field such as pharmacy, biology, chemistry, or biological science.
• Minimum 10 years of relevant experience from the biopharmaceutical industry or other relevant experience.
• Breadth of knowledge in manufacturing, project, technical, and regulatory management.
• IT Skills
• Partner & Project management
• Professional capabilities: Regulatory knowledge
  

Desirable Skills/Experience:

• Knowledge of the drug development process and regulatory submissions
• Understanding of current regulatory CMC requirements
• Direct/indirect Regulatory Affairs CMC experience with submissions for synthetics and/or biologic products
• Understanding of regulations governing the manufacture of biotechnology products
• Lean capabilities
  

When we put unexpected teams in the same room, we ignite bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. Thats why we work, on average, a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
At AstraZeneca, we are driven by a shared vision to eliminate cancer as a cause of death. Our team is dedicated to pioneering new frontiers in Oncology, fusing innovative science with the latest technology to achieve breakthroughs. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we are committed to delivering new molecular entities by 2025. Our culture is built on courage, curiosity, and collaboration, empowering you to lead at every level and take smart risks that shape the future of our pipeline. Join a community that unites academia and industry, expediting research in some of the hardest-to-treat cancers.
Ready to make bold decisions and drive change Apply now to join our team!