Reg Affairs Manager, CMC

The Opportunity:

CSL Seqirus has an exciting opportunity for a Manager, Regulatory Affairs, Chemistry Manufacturing & Control (CMC) to join our expanding team in Parkville, a leader in egg-based influenza vaccine manufacturing, in-licensed vaccines and specialty pharmaceuticals. CSL Seqirus is the sole supplier of a unique range of products made in the national interest for the Australian Government. Together, we are working on the front line to protect communities from seasonal influenza and global pandemic threats.

Reporting to the Head of GRA CMC at the Parkville site, this technical strategic role contributes to the vision and goals for Global Regulatory Affairs and CSL Seqirus, by providing specialist strategic advice and support to Project/Product teams, Quality Operations and Manufacturing Operations. The main responsibilities include:

• Lead the development and implementation of the global CMC regulatory strategy for Seqirus development programmes/products, licenced through all development phases to registration/licensure and approval/post approval lifecycle stages.

• Lead the authoring, preparing and compiling of high quality, submission-ready CMC documentation for Health Authority (HA) submissions in Seqirus territories.

• Ensure compliance of CMC regulatory dossiers with manufacturing and quality control processes.

• Support global CMC regulatory and change control policies and procedures.

• Provide strategic regulatory expertise and guidance for the development and review of technical protocols and reports (e.g. assay development, validation, stability, product development)

• You will assess and communicate inspectional findings applicable to products and support CAPA projects as applicable.

• Contribute to the global regulatory intelligence database and help draft company position statements and responses to pending changes to regulatory legislation, Regulatory Agency Discussion Papers/White Papers

• Contribute to the development of the budget preparation and resource planning, and monitor progress for product(s)/ projects.
   

Skills & Experience:

• A degree in Biological Science, Allied Medical discipline or Pharmacy; preferably with a Masters, or complementary experience in the pharmaceutical/ biotechnology industry.

• 7+ years' of hands-on regulatory experience with knowledge and experience in CMC. Additional experience in a similar pharmaceutical and manufacturing environment e.g., QA or manufacturing or technical/product development will be beneficial.

• Strong attention to detail and communication skills.

• Ability to analyse data, communicate opportunities and implications for the business.

• Excellent project management skills with ability to negotiate with all partners.
   

Come join CSL, a company that tackles fascinating problems and finds solutions to complex challenges. Excited to apply? Please apply with your updated resume by 11th March 2024.

CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join CSL Seqirus.

CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. In Australia, CSL Seqirus is also a leading provider of speciality pharmaceuticals and other essential vaccines. Learn more about CSL Seqirus.

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

Watch our ‘On the Front Line’ video to learn more about CSL Seqirus