CMC Regulatory Affairs Director

CMC Regulatory Affairs Director

Location: Gothenburg, Sweden

Are you a strategically focused CMC professional who 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 CMC Regulatory Affairs Director will provide CMC Regulatory Strategy and decision-making expertise for projects and complex product ranges from early clinical development phase through to launch for major markets.

You will provide support across CMCRA for products/projects and/or specialist skill areas, bringing a deep understanding of dossier complexities and a proven ability to plan long‑term, manage interdependencies, and deliver against critical milestones.

You will represent CMC Regulatory Affairs (CMCRA) in networks across the business including Pharmaceutical Development Project teams, Global Regulatory Strategy Teams, Global Supply Teams, Global Quality and Operations and, where applicable, external industry groups.  In doing so you will facilitate high quality partnerships within and external to AstraZeneca.   You will actively grow and share your regulatory knowledge to build the group and will contribute to the development of new guidance, policy and processes that will shape the future of CMCRA.

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, manufacturing capacity expansion.
• Lead policy setting and strategy development in the CMC RA environment within or external to AstraZeneca. 
• Share knowledge, leading/contributing to Communities of Practice 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 recommendations 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 deliver 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
• Breadth of knowledge of manufacturing, project, technical and regulatory project management 
• Strong understanding of regulatory affairs globally  
• Direct experience with CMC Regulatory submissions for chemically synthesised molecules  
• Experience of clinical development of innovative pharmaceutical APIs and Drug Products
• Regulatory experience in at least one of the following areas: inhalation, modelling, advanced manufacturing, or complex APIs such as oligonucleotides, conjugates, PROTACs, or peptides
• Stakeholder & Project management skills  

Desirable for the role: 

• Masters degree or PhD in Science, Regulatory Sciences or Pharmacy
• Experience of regulatory health authority interactions, inspections and/or external advocacy/regulatory policy
• Experience in Line and/or matrix leadership 

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! 

Where can I find out more? 

Our Social Media,  

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Date Posted

10-Nov-2025

Closing Date

29-Nov-2025

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.