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Regulatory Affairs Specialist CMC
2 months ago
We're seeking a highly skilled Principal Associate, Regulatory Affairs CMC to provide strategic advice and support to our Project/Product teams, Quality, and Operations. As a key member of our team, you will be responsible for developing and implementing the global CMC regulatory strategy for our development programs/products, ensuring compliance with manufacturing and quality control processes, and providing strategic regulatory expertise and guidance for the development and review of technical protocols and reports.
Requirements- Tertiary degree in Biological Science, Allied Medical discipline, or Pharmacy, with post-graduate qualifications or complementary experience in the pharmaceutical/biotechnology industry.
- 3+ years' regulatory experience with specific knowledge and experience in CMC.
- Experience in a biologicals or biotechnology manufacturing environment, such as QA, manufacturing, or technical/product development.
- Excellent project management skills.
CSL is a purpose-driven, values-based organisation committed to protecting public health. We're driven by our promise to patients and human health, and we're committed to providing a workplace that's respectful of your professional and personal lives, inclusive, and supportive of your career aspirations and potential.
Our BenefitsAt CSL, we offer a competitive compensation package, comprehensive benefits, and multi-dimensional wellbeing programs and recognition programs that support your physical, emotional, financial, and social health and wellbeing.
Why Join CSL?CSL is a global organisation with employees in 35+ countries, and we're committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. We're a leader in the prevention of influenza globally and a transcontinental partner in pandemic preparedness.
