AstraZeneca
Associate Director Regulatory Affairs
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Associate Director Regulatory CMC
Duration: 12 months
Location: Remote, UK (must be able to attend HQ if required)
IR35 Status: Outside
About AstraZeneca
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
Role Summary
The Associate Director/Director provides international regulatory CMC knowledge and progressively increasing levels of expertise to TA and non-TA projects across International Regulatory Affairs and AstraZeneca’s technical functions, typically with responsibility for new chemical entities, biologics, line extensions and post-marketing activities. The role holder effectively manages projects or complex product ranges across the portfolio throughout the product lifecycle to deliver the needs of both the AZ business and the customer, demonstrating strong project management and tactical delivery expertise.
They are accountable for interfaces with CMC Product Leads and proactively partner with stakeholders across the AZ organisation to help deliver and implement innovative, risk-based regulatory strategies. They define the strategy and content of international CMC submissions and project-manage their delivery, ensuring project activities and documentation are delivered to the required standard, agreed timelines, and business, compliance and worldwide Health Authority expectations. The role holder ensures the application of international CMC regulations and guidance within AstraZeneca and leads or contributes to the development of new guidance, policy and processes.
International CMC Regulatory Technical Transfer
The Associate Director/Director leads the regulatory CMC aspects of manufacturing technical transfers and site changes, ensuring continuity of supply and ongoing compliance with the registered dossier across international markets.
- Lead regulatory risk assessments for technical transfers and review supporting documentation, including transfer protocols, gap analyses, deviations and submission sequencing.
- Define international regulatory strategies for manufacturing site changes across drug substance, drug product, testing laboratories and packaging operations.
- Assess the regulatory impact of proposed changes and determine appropriate reporting categories and supporting data requirements across international markets.
- Review comparability, process validation and stability data to ensure submissions demonstrate equivalence and meet Health Authority expectations.
- Define the application of Post-Approval Change Management Protocols and comparability protocols across international regions to enable efficient change implementation and maintain operational flexibility.
- Conduct gap analyses between sending and receiving sites, ensuring alignment with registered dossiers and identifying required regulatory actions.
- Define market implementation and submission sequencing strategies in partnership with Supply Chain to balance regulatory approvals, inventory management and supply continuity.
- Partner with technical, quality, supply, commercial and manufacturing functions to integrate regulatory requirements throughout the transfer lifecycle.
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Key Responsibilities
- Define international CMC submission strategy and content, and review and approve regulatory CMC documentation to ensure alignment with cross-functional strategy and operational flexibility.
- Manage the timely preparation and delivery of international CMC contributions across the product lifecycle, including clinical, marketing authorisation and post-approval submissions.
- Lead complex international CMC regulatory programmes, ensuring compliance, quality, timely delivery and maintenance of Health Authority approval status.
- Lead international CMC submission teams, ensuring submission documentation is fit for purpose and supports future operational flexibility.
- Represent International CMC on Regulatory Project Teams, ensuring regional CMC considerations are effectively communicated and integrated across key stakeholders.
- Facilitate CMC-related interactions with Health Authorities within the international region.
- Provide strategic international CMC regulatory guidance and interpretation of regulatory requirements to support business and operational objectives.
- Lead risk assessment and mitigation activities, making sound judgements to address complex regulatory challenges.
- Apply project management expertise to drive delivery, manage priorities and support resource planning.
- Ensure compliance with GxP requirements and lead assigned change management activities.
- Lead or contribute to strategic business initiatives and critical regulatory processes supporting submissions, launches and regulatory compliance.
- Promote knowledge sharing and provide coaching within CMC Regulatory Affairs and across partner functions.
- Participate in regulatory delivery forums and communicate relevant updates to the International Regulatory Team.
Education, Qualifications, Skills & Experience
- Advanced degree or equivalent qualification in a scientific or technical discipline such as pharmacy, biology, or related fields.
- Significant experience within the biopharmaceutical industry or a comparable scientific environment.
- Broad expertise in manufacturing, technical, project and regulatory management.
- Strong knowledge of international regulatory affairs and CMC requirements.
- Proven Regulatory Affairs CMC experience across the product lifecycle, including marketing authorisations, variations and renewals.
- Demonstrated leadership of the regulatory CMC aspects of technical transfers and manufacturing site changes, including transfer protocols, comparability assessments, gap analyses, deviations and submission sequencing across international markets.
- Strong stakeholder engagement, influence and project management skills.
- Direct CMC Regulatory Affairs experience supporting submissions for synthetic, biologic and biotechnology-derived products, including monoclonal antibodies and complex biologics.
- Strong knowledge of regulatory requirements and guidance governing the development and manufacture of biotechnology products.
- Experience applying Post-Approval Change Management Protocols (PACMPs) and lifecycle management approaches (e.g. ICH Q8–Q12, Q5E) to support manufacturing changes.
- Proven ability to manage resource planning and prioritisation for complex regulatory projects.
- Demonstrated Lean capability to drive process efficiency and continuous improvement.
- Strong understanding and application of Quality Risk Management principles.
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Compliance & Continuous Improvement
- Demonstrate company values and ethical leadership in all activities, ensuring compliance with applicable policies, standards, GxP and SHE requirements, and promptly escalating potential compliance concerns.
- Complete all required training and maintain a strong commitment to regulatory, quality and ethical standards.
- Drive a culture of continuous improvement by adhering to established processes, identifying and resolving issues, and implementing sustainable improvements.
- Lead by example in fostering a learning, performance-driven and continuous improvement culture.
Why AstraZeneca?
At AstraZeneca we’re dedicated to being a Great Place to Work, where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. You will be part of an inclusive, diverse, collaborative and high-performing culture that empowers individuals to innovate, challenge convention and deliver meaningful outcomes for patients, science and society. We foster continuous learning, professional growth and an entrepreneurial mindset, enabling our people to drive excellence, embrace new opportunities and help pioneer the future of healthcare.
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