At AstraZeneca, we make a difference every day by delivering life-changing medicines to millions of people globally. Our purpose is ambitious and so is our approach. Creating a more agile and inclusive environment means building an inspiring culture where we celebrate innovative thinking.

The Chief Medical Office (CMO) is an integrated, enterprise-wide organisation dedicated to defining the benefit/risk assessment of our medicines across the life-cycle, acquiring and maintaining their health authority approvals around the world, and ensuring they are accessible for patients. Join us and become part of a #GreatPlaceToWork!

The Regulatory Affairs Associate Director – CMC (Chemistry, Manufacturing & Controls) leads CMC regulatory strategy that incorporates risk identification and contingency planning for assigned post-approval and global marketing authorisation applications for biologic products (particularly monoclonal antibodies).

You will be a Regulatory Affairs representative on operations led teams and have responsibility for delivery of CMC post-marketing submissions and global marketing applications, ensuring that they meet regulatory standards, are high quality, consistent, complete, and approvable in the first review cycle.

Activity includes, but is not limited to:

• Partner with Regulatory Affairs therapeutic leads to ensure alignment of strategy for a variety of monoclonal antibody programs and participate on due diligence teams as needed
• Coordinate and deliver CMC regulatory sections for submission to Health Authorities
• Participate and/or lead multi-disciplinary teams or task-forces related to CMC
• Lead interactions with FDA or other HA’s as they pertain to CMC
• Collaborate with all relevant groups to ensure high quality CMC documentation is developed
• Meet with relevant individual/groups on a regular basis to provide input on major regulatory CMC submissions and CTD development
• Interact effectively with external business partners

Essential Skills:

• BS/MS or Ph.D. in a scientific discipline
• Experience working directly in Regulatory Affairs – CMC
• Increasing documented success in a biopharmaceutical field specifically working on biotechnology-based products or complex biologics
• Understanding of regulations and guidance governing the manufacture of biotechnology products, especially monoclonal antibodies

Desirable Skills:

• Global marketing application experience
• Post-marketing submission experience
• Technical experience in the testing or manufacture of biotechnology-derived products or complex biologics.
• Experience with change control systems and assessments.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.