Brookfield

The Opportunity

We have an exciting opportunity for a Regulatory Project Manager, CMC & Compliance based at our Holly Springs site. Reporting to the Senior Manager, Regulatory Affairs Site Head, The RA manager, CMC & Compliance role is a technical strategic role within the CMC and Compliance Group. The role contributes to the vision and goals for Global Regulatory Affairs and Seqirus, by providing specialist strategic advice and support to Project/Product teams, Quality Operations and Manufacturing Operations.

The Role

• In association with colleagues ensure CMC dossiers meet content requirements for applicable territories
• Lead the authoring, preparing and compiling of high quality, submission-ready CMC documentation for HA submissions in Seqirus Territories
• Ensure compliance of CMC regulatory dossiers with manufacturing and quality control processes
• Provide strategic regulatory expertise and guidance to develop technical protocols and reports (e.g. assay development, validation, stability, and product development)

Your skills and experience

• A degree in Biological Science, Allied Medical discipline or Pharmacy; preferably with a Master's or PhD, or complementary experience in the pharmaceutical/ biotechnology industry
• 7 years' regulatory experience with regulatory knowledge and experience in CMC.
• You will have Project Management experience in the CMC world
• Additional experience in a biologicals or biotechnology manufacturing environment e.g., QA or manufacturing or technical/product development is advantageous

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

About CSL

CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL.

We want CSL to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

Do work that matters at CSL!