CMC Regulatory Affairs Associate Director

CMC Regulatory Affairs Associate Director

Are you a strategically focused Regulatory CMC professional and would like to play an integral part in bringing life changing medicines to patients? If you are please read on! 

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.

The Regulatory Affairs CMC Associate Director will provide appropriate CMC Regulatory Strategy, operational, tactical, and decision-making expertise for projects and complex product ranges from early clinical development phase through to launch and post approval lifecycle management for global markets. 

This role will represent CMC Regulatory Affairs in networks across the business including Pharmaceutical Development Project teams, Global Regulatory Strategy Teams, Global Supply Teams, Global Quality and Operations. The role holder may lead development of new guidance, policy, and processes. They will also be a key partner for identified customer functions to facilitate high quality partnerships within and external to AstraZeneca. The role will support across CMCRA for products/projects and /or specialist areas. The Regulatory Affairs Associate Director will have an in depth understanding in the complexity and challenges that are required for Dossier submissions and have proven project management skills. 

What you’ll do

• Provide CMC RA expertise across the business functions. May lead key business improvement initiatives. May sit on external industry groups. 
• Provide strategic CMC RA expertise and direction for CMC submissions across the lifecycle of a product.  Provide novel strategies and support new approaches from the technical functions.
• Where necessary lead CMC related interactions with Health Authorities.  
• Accountable for the provision of regulatory strategic guidance in support of Operational initiatives, for example complex/accelerated projects and/or post approval changes. 
• Contribute to or lead policy setting and strategy development in the CMC RA environment within or external to AstraZeneca. 
• Share knowledge, leading/contributing to Community of Practises across the groups or within a business unit. 
• Accountable for managing high level risk by making complex judgments, developing innovative solutions including proactive risk management and mitigation. 
• Provide AZ technical functions clear, concise guidance on current CMC regulatory requirements to support business tactical and strategic planning. Provide expert recommendation and decisions on regulatory issues relating to CMC. 
• Support the development and implementation of novel strategies in CMC regulatory affairs to enhance efficiency and flexibility in the CMC dossier.
• Contribute to cross therapeutic non-drug projects and support business processes to ensure accelerated submissions, support launch activities / ensure management of regulatory information and ensure regulatory compliance on behalf of AZ.  

Education, Qualifications, Skills and Experience

Essential for the role:

• Bachelors degree in Science, Regulatory Sciences or Pharmacy with 10+ years of experience or
• Masters degree in Science, Regulatory Sciences or Pharmacy with 6+ years of experience
• Breadth of knowledge of manufacturing, project, technical and regulatory project management 
• Strong understanding of regulatory affairs globally  
• Direct Regulatory Affairs CMC experience with submissions for Synthetics and/or biologic and biotechnology derived products  
• Stakeholder & Project management  

Desirable for the role:

• Expertise in at least one of the following areas: inhalation, modelling, advanced manufacturing, or complex APIs such as oligonucleotides, Conjugates, PROTACs, or peptides.
• Experience of regulatory health authority interactions, inspections and/or external advocacy/regulatory policy
• Experience in Line and/or matrix leadership 
• Experience of clinical development of innovative pharmaceutical APIs and Drug Products

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. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare. 

So, what’s next? 

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you! 

Competitive salary and benefits package on offer.

The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save plans, A performance recognition scheme and a competitive, generous remuneration package. 

Where can I find out more?

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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

Date Posted

17-Jul-2025

Closing Date

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.