Job Description
The Opportunity
Reporting to the Associate Director, Regulatory Affairs you will be responsible for CMC regulatory activities related to product development, registration and license maintenance for the assigned products and intermediates.
As a permanent member of the Global Regulatory Affairs Strategy Team (GRAST(s)) and of relevant CMC Regulatory Sub-Team, you will contribute to the development of global CMC regulatory strategies regarding product development, clinical trial applications, new license applications, product changes and CMC projects related to the assigned products and intermediates.
You will also manage the compilation and maintenance of facility and equipment information for regulatory submissions and works together with relevant technical expert departments.
The Role
Responsible for operational CMC regulatory activities related to the assigned products and/or intermediates, including as applicable:
- Maintenance of the content of relevant parts of the regulatory dossiers.
- Preparation, revision and review of Module 2.3, Module 3, required facility and equipment information and related documents for new product registrations (e.g.
- MAAs, BLAs) and life cycle submissions according to agreed timelines and taking regional regulatory requirements into account. This may include technical authoring of dossier narratives and other regulatory CMC documentation.
- Timely provision of high quality responses to CMC related Health Authority questions.
- Compilation and review of CMC information for CTAs, INDs and other regulatory submissions related to product development (e.g. CMC documentation for Scientific
- Advice Meetings, Briefing Books, IBs).
- Provision or support of timely and compliant regulatory assessments as well as efficient execution of CMC changes.
- Preparation and review of CMC related information and documentation required for tenders, PSURs, DSURs, CCDS/product information and promotional materials.
- Regulatory contribution to annual product quality reviews and risk assessments
Your skills and experience
- University degree in natural sciences (BS/BA/MS or equivalent), a degree in Regulatory Affairs is advantageous
- 1 or more years of experience in the biotech or pharmaceutical industry.
- Sound knowledge in natural sciences with a focus on biological medicinal products
- Flexibility to work in a global cross-cultural work environment.
Apply now to join Australia's leading biopharmaceutical company! Please include a covering letter addressing the selection criteria and an up-to-date CV.
Applications Close on December 15th
Our Benefits
We encourage you to make your well-being a priority. It's important and so are you.
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.
We want CSL to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion.
Do work that matters at CSL!
About Us
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 Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.
Do work that matters at CSL Behring!