GRA CMC Specialist — CSL Behring

Role overview

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 with plasma source lifecycle management, including new plasma source registrations, maintenance activities, and change control assessments.

• Collaborate with cross functional teams to support regulatory strategy development, change management activities, technical assessments, and regulatory risk evaluations.

• Support interactions with global regulatory authorities and contribute to the preparation of health authority communications, briefing materials, and scientific or regulatory discussions.

• Support regulatory activities associated with U.S.

plasma center licensing and maintenance activities, including coordination of documentation and support for regulatory inspections and submissions.

• Contribute to scientific and technical regulatory evaluations related to plasma collection, plasma manufacturing processes, and biologic product lifecycle management.