Typical Accountabilities:
• Provides CMC regulatory and compliance advice on regulatory post-approval submissions
• Works cooperatively with stakeholders across CMCRC, AZRA and Operations
• Project manage timely submission of post approval CMC documentation
• Review and approve regulatory CMC documents
• Generates documentation of submission-ready components to support lifecycle submissions
• Delivers documentation to Global Regulatory Affairs for worldwide use in regulatory submissions
• Notifies manufacturing sites of health authority approvals
• Updates all relevant electronic systems (including CMC change management, GEL and SLiM) to be consistent with regulatory submissions and commitments.
• Provides Regulatory Intelligence to support the operational and tactical regulatory CMC contribution and direction to AstraZeneca product and project teams in support of drug products throughout the life cycle.
• Shares learnings from own projects with other colleagues within the department and other relevant project/product teams
• Demonstrates compliance with departmental and company standard operating procedures and processes
Typical People Management Responsibility (direct / indirect reports):
• Approximate number of people managed in total (all levels) - 0
• Matrix Manager – (projects/dotted line)
What is the global remit? (how many countries will the role operate in?):
• Remit which covers all AstraZeneca countries
Education, Qualifications, Skills and Experience:
• Essential: University degree; Considerable experience of drug development in the pharmaceutical industry; Expertise in information and document management technology and electronic/paper publishing software; Excellent written and verbal communication skills; Complete understanding of current regulatory CMC requirements; Project management skills
• Desirable: Resource management skills; Team management skills; International work experience; Influencing and negotiating skills; Leadership skills, including proven leadership of global cross-functional project teams
Key Relationship to reach solutions:
• Internal (to AZ or team): Operations function; Global regulatory leads
• External (to AZ):
Date Posted
08-12月-2025Closing Date
27-2月-2026AstraZeneca 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.