The Opportunity: Reporting to the Associate Director, Regulatory Affairs monitor and report progress consistently to stakeholders.
Stay updated on local regulatory requirements, guidelines, and industry trends to ensure compliance with evolving regulations.
Plan, coordinate, track and communicate effectively local requirements and submission deadlines.
Registration projects for CSL Behring products according to Company priorities.
License maintenance, prepare, submit, and follow up variations and renewals for all CSL Behring products.
Labelling, ensure country specific labelling requirements are fulfilled.
Coordinate, review, and approve art works for the implementation of packaging materials.
Simplified local batch release process and GMP inspection request.
Obtain local batch release for biological products.
Keep update importing licenses for all CSL Behring products.
Evaluate and submit promotional materials to ensure compliance with local ...