CMC Regulatory Affairs Associate Director, Submission Excellence & Project Management
About this role
Are you passionate about the application of science to deliver life‑changing medicines? We are looking for a Chemistry, Manufacturing and Control Regulatory Affairs (CMC RA) Associate Director to join our Respiratory and Immunology team in Biopharm Synthetics.
About Chemistry, Manufacturing and Controls Regulatory Affairs
Our CMC RA function spans the full product lifecycle and is responsible for the regulatory strategy relating to the development, manufacture, and testing of all AstraZeneca medicines. With our expertise we interpret, anticipate, and shape global Health Authority expectations to build insightful CMC and Device Regulatory Strategies.
We are the bridge between our R&D functions, Operations sites, Quality and Global Supply Teams—helping safe, effective medicines reach the right patient at the right time. We manage the timely preparation and delivery of CMC contributions to regulatory submissions across the lifecycle, including Clinical Trial Applications (CTAs), Marketing Authorisation Applications (MAAs), and post‑approval activities. We improve the reliability and value of business‑critical Supply Chain changes by supplying the regulatory context, intelligence, and mentorship for robust approval and change management.
What you’ll do
Project manage the timely preparation and delivery of CMC contributions to the regulatory submissions linked to medicinal products throughout the lifecycle, including clinical programs, marketing authorisation applications and all post‑approval activities.
Project manage complex global CMC regulatory programmes ensuring that project activities and documentation are delivered to the required high standard, agreed timelines, and meet the business requirements; ensure compliance with the registered dossier content through maintenance and communication of Health Authority approval status.
Lead appropriate CMC teams and ensure the delivery of submission documentation which is fit for the intended purpose with appropriate consideration of the desire for subsequent operational flexibility.
Provide support for CMC‑related interactions with Health Authorities, as needed.
Act as Subject Matter Expert (SME) or Process expert, contributing to and advising project teams.
Give advice, train and mentor other team members.
Identify resource needs for relevant CMC submissions across the product lifecycle
Own change management activities as assigned
Apply GxP principles according to the stage of product lifecycle and take responsibility for change management as assigned.
Lead/contribute to cross SET non‑drug projects to ensure accelerated submissions, support launch activities/management of regulatory information and ensure regulatory compliance on behalf of AZ.
Apply expertise in regional regulatory requirements to assure compliance of CMC submissions and apply an appropriate level of risk management across activities.
Participate in regulatory execution and delivery meetings and communicate and provide relevant updates to the CMC team.
Conduct activities consistent with Company Values and in compliance with the Code of Ethics and supporting Policies and Standards (including SHE).
Contribute to AstraZeneca’s continuous improvement culture by following processes and standards, identifying and solving problems, and defining and implementing improvements
Requirements
- Bachelor’s degree in Science, Regulatory Sciences or Pharmacy.
- Breadth of knowledge of manufacturing, project, technical and regulatory management.
- Strong understanding of regulatory affairs globally.
- Stakeholder and Project management experience.
- 4 years’ experience in Regulatory/Drug development (Industry or Health Authority)
- Desirable requirements
- Master’s degree or PhD in Science, Regulatory Sciences or Pharmacy.
- 7 years’ experience in Regulatory/Drug development (Industry or Health Authority)
- Direct CMC Regulatory Affairs experience with submissions for synthetics and/or biologic and biotechnology‑derived products such as monoclonal antibodies or complex biologic products.
- Lean capability and Quality Risk Management.
- Experience managing resource requirements for pivotal projects.
- Location and remit
- Location
- : Gärtuna (Sweden)
- Global remit
- : Operates across multiple regions and markets in collaboration with global and local teams
- Why AstraZeneca?
- When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
- Embrace the opportunity for development – whether it’s upskilling or reskilling. We are a high-performing learning organization with autonomy over how we learn. We deliver innovative development experiences that sustain and grow future leaders and talent. Because we want all our people to embrace the cha
- So, what’s next?
- Are you ready to take the next step in your career and become part of our amazing team? We look forward to receiving your application.
- Date Posted
- 24-apr.-2026
- 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.