CMC RA Associate Director Submission Excellence & Project Management

As a CMC RA Associate Director for Submission Excellence & Project Management, you will manage complex product ranges across the portfolio throughout the product lifecycle. You will demonstrate strong project management and tactical delivery expertise, ensuring that global CMC regulatory submissions meet the required standards and timelines. You will partner with stakeholders across AstraZeneca to implement innovative risk-based regulatory strategies and drive the delivery of regulatory CMC components for business-related projects.

Accountabilities
• Manage the timely preparation 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.
• Project manage complex global CMC regulatory programs ensuring that project activities and documentation are delivered to the required high standard, agreed timelines, and meet business requirements.
• Lead appropriate CMC teams, ensuring the delivery of submission documentation which is fit for the intended purpose with appropriate consideration of the desire for subsequent operational flexibility.
• Apply project management expertise with the ability to adapt to changing situations to ensure timely delivery.
• Act as Subject Matter Expert (SME) or Business Process Owner (BPO)/Sub-Process Owner (SPO) contributing to and advising project teams.
• Provide advice, training, and mentorship to other team members.
• Highlight resource needs for products as appropriate for effective planning purposes.
• Apply GxP principles according to the stage of the product lifecycle.
• Responsibility for change management as assigned.
• Lead/contribute to cross SET non-drug projects to ensure accelerated submissions, support launch activities, manage regulatory information, and ensure regulatory compliance on behalf of AstraZeneca.
• Ensure assurance of compliance of CMC submissions with regional regulatory requirements.
• Apply an appropriate level of risk management across activities.
• Participate in regulatory execution and delivery meetings and communicate relevant updates to the CMC team.
• Follow processes and work to standards, identify and solve problems, define and implement improvements, and lead by example in creating a learning and continuous improvement culture.

Essential Skills/Experience
• Bachelors degree in Science, Regulatory Sciences or Pharmacy.
• 4 years experience in Regulatory/Drug development (Industry or Health Authority)
• Breadth of knowledge of manufacturing, project, technical and regulatory management.
• Strong understanding of regulatory affairs globally
• Stakeholder & Project management

Desirable Skills/Experience
• Masters degree or PhD in Science, Regulatory Sciences or Pharmacy.
• 7 years experience in Regulatory/Drug development (Industry or Health Authority)

• Direct Regulatory Affairs CMC experience with submissions for Synthetics and/or biologic and biotechnology derived products such as monoclonal antibodies or complex biologic products
• Understanding of regulations and guidance governing the manufacture of biotechnology products, especially monoclonal antibodies

When we put unexpected teams in the same room, we unleash 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. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Ready to make a difference? Apply now and be part of our journey!