Regulatory Affairs Cmc Scientist

The Opportunity

CSL is looking for a Global Regulatory Affairs (GRA) CMC Scientist to join the team at the Melbourne office (Australia).

Reporting to the Associate Director – GRA Plasma Lead (ANZAP), you will be responsible for Chemistry, Manufacturing & Controls (CMC) regulatory activities related to, registration and license maintenance for CSL products. You will be a regulatory interface for plasma sourced from Australia, New Zealand, Asia Pacific (ANZAP) toll and commercial markets.

You will represent manufacturing sites at Global Regulatory Affairs Strategy Team (GRAST) meetings on plasma matters for plasma sources registered in ANZAP.

The Role

• Work closely with the GRA Plasma Lead(s) to support plasma registration and maintenance pertinent to locally manufactured products and plasma fractionation intermediates as applicable.
• Be a designated GRA support for plasma during GMP inspections and for preparation of relevant information, coordinating incoming questions from an inspection within GRA and assess and communicates inspectional findings.
• Be the CMC regulatory subject matter expert for the assigned tasks and activities. Contribute to the development of global regulatory processes in agreement the manager.
• Contribute to the development, implementation and maintenance of globally aligned strategies, procedures and tools supporting change control and deviations activities within Global Regulatory Affairs (GRA) related to plasma CMC changes.
• Work towards global harmonization of regulatory plasma change assessments and deviations support strategies. You will help develop strategies and tools to facilitate regulatory change assessment processes to increase efficiency and ensure compliance.
• Represent Global Regulatory Affairs in Core Project Teams for global CMC projects as an expert for regulatory advice related to plasma.
• Technical authoring of dossier narratives (Module 2.3, Module 3) and other regulatory CMC documentation for new product and life cycle submissions according to agreed timelines and taking regional regulatory requirements into account. Work in collaboration with relevant technical expert departments. Provide high-quality responses to CMC related Health Authority questions.

Your skills and experience

• University degree in natural sciences (BS/BA/MS or equivalent), a degree in Regulatory Affairs is advantageous.
• 1 to 3 years' experience in the biotech or pharmaceutical industry.
• Sound knowledge in natural sciences with a focus on biological medicinal products.
• Excellent communication, project management, planning, problem solving and presentation skills.
• Strong Team player with a demonstrated ability to develop constructive and effective relationships with peers and management.
• Ability to work with minimal supervision based on sound technical and analytical judgment.
• Strong organizational and follow-up skills, as well as attention to detail.
• Flexibility to work in a global cross-cultural work environment and outside of normal business hours.

How to Apply

Please submit your application including resume by 21 April 2024.

Apply now to join Australia's leading biopharmaceutical company, committed to protecting public health!

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