Astra Zeneca is a major international healthcare business engaged in the research, development, manufacture, and marketing of prescription pharmaceuticals and the supply of healthcare services. Astra Zeneca is proud to offer a unique workplace culture that inspires innovation and collaboration.
For our close partner Astra Zeneca, Kelly OCG is seeking a CMC Regulatory Affairs Associate on a 12-month contract, with the possibility of contract extension and further collaboration opportunities. You will work entirely onsite at Astra Zeneca in Södertälje, becoming an integral part of their team and reporting directly to their manager.

The arena:
We are looking for a motivated and engaged CMC Regulatory Affairs Associate to join our Chemistry, Manufacturing, and Controls (CMC) Regulatory function at Astra Zeneca in Södertälje. As a CMC RA Associate, you will apply your knowledge of regulatory processes to support the management of product divestments to 3rd party customers. This role involves collaborating with internal stakeholders, interpreting global health authority expectations, and providing regulatory and compliance advice to ensure the compliant supply of products. You will work within Astra Zeneca’s CMC RA Business Development Team, bridging R&D, Operations, Quality, and Global Supply Teams to help ensure that safe, effective medicines reach the right patients at the right times.

Tasks and responsibilities/The role:
This is an exciting opportunity for you to join us as a CMC RA Associate to support the regulatory contributions required for product divestments. You will work closely with Astra Zeneca stakeholders and external customers, providing regulatory and compliance advice to ensure a smooth product transfer process. Your role will include preparation of regulatory submissions, maintaining regulatory documentation, and managing regulatory commitments. You will also contribute to training initiatives, develop user support materials, and help improve related business processes. Your contributions will support projects throughout Astra Zeneca's drug development pipeline.

Key responsibilities include:

• Assisting in the preparation of regulatory submissions and documentation in line with customer requirements and timelines.
• Uploading, retrieving, and maintaining documents for electronic submissions using appropriate software and applications.
• Managing the maintenance and filing of regulatory-related documentation and tracking commitments.
• Training and guiding colleagues, developing training materials, and supporting business administration tasks.
• Interacting with cross-functional teams to support submission development and project coordination.
• Contributing to process improvement and sharing learnings with colleagues.

Essential requirements:

• Foundational/Associate degree in Regulatory Sciences, Pharmacy, or Pharmaceutical Sciences.
• Teamworking skills.
• IT skills.
• Experience in Regulatory Affairs or Quality Assurance.

Desirable in the role:

• Bachelor's degree in Science, Regulatory Sciences, Pharmacy, or Pharmaceutical Sciences.
• Basic knowledge of the regulatory submissions process.
• Understanding of current regulatory CMC requirements.
• Basic understanding of regulations governing the manufacture of biotechnology products.
• Lean approach and Quality Risk Management capabilities.

The final date to apply is October 19th. However, we review applications and conduct interviews on an ongoing basis, and positions may be filled before the deadline. If you're interested, we encourage you to apply as soon as possible!
Why Astra Zeneca?
Thrive in a place where the brightest and most curious minds seamlessly come together in our inclusive environment. This is the place to go beyond discovery - we think holistically about patients and are always learning from those living with diseases.
Astra Zeneca is one of the world’s most exciting biopharmaceutical companies. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life-changing medicines that improve patients’ lives and benefit society. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world.