Job Description
Description
Responsibilities:
Plan, support, and monitor regulatory affairs activities related to plasma derived medicinal products and human plasma as starting material to ensure compliance with global regulatory requirements and support current and future business activities. Support the preparation, review, and maintenance of regulatory documentation for Plasma Master Files (PMFs), plasma source registrations, and related submissions for the European Union, Switzerland, and international markets. Support preparation and submission of regulatory applications, variations, renewals, responses to health authority questions, and other regulatory filings related to plasma and biologic products. Contribute to the assessment and implementation of regulatory requirements, guidelines, and emerging regulations impacting plasma derived products, plasma collection, and related manufacturing processes. Support regulatory activities associated...
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