Principal Associate Regulatory Affairs Cmc

2 weeks ago

Melbourne, Australia CSL Full time

We're looking for a Principal Associate, Regulatory Affairs CMC to join our team. In this strategic position, you will provide specialist strategic advice and support to Project/Product teams, Quality and Operations. Reporting to the local Head of GRA CMC your main responsibilities include:

- Develop and implement the global CMC regulatory strategy for Seqirus development programs/products, licenced through all development phases to registration/licensure and approval/post approval lifecycle stages.
- In association with GRA Regions colleagues ensure CMC dossiers meet content requirements for applicable territories.
- Lead sub-teams of regulatory and cross-functional experts to ensure author, preparation and compilation 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 for the development and review of technical protocols and reports.

Your Experience:

- Tertiary Degree in Biological Science, Allied Medical discipline or Pharmacy; preferably with post-graduate qualifications, or complementary experience in the pharmaceutical/ biotechnology industry.
- 3+ years' regulatory experience with specific knowledge and experience in CMC preferred.
- Experience in a biologicals or biotechnology manufacturing environment e.g., QA, manufacturing or technical/product development advantageous.
- Excellent project management skills

At CSL, we’re driven by our promise to patients and human health. We’re also driven by our promise to employees, which is Promising Futures - our commitment to helping you fulfill your career aspirations and potential. You’re our greatest asset and you help drive CSL’s superior performance. We’re committed to providing:

- A workplace that’s respectful of your professional and personal lives — and inclusive, so you feel comfortable bringing your whole self to work.
- Total rewards that include a competitive compensation package, comprehensive benefits, and multi-dimensional wellbeing programs and recognition programs, all of which support your physical, emotional, financial, and social health and wellbeing.
- Career, performance and development programs that enable success in your current position and foster your development and growth.

Applications Close on 6 October, 2024

**Our Benefits**:
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.

**About 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.

**We want CSL Seqirus 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 Seqirus.

**Do work that matters at CSL Seqirus**:

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