Regulatory Affairs Manager for IMP Labeling

Advance your career with Telix Pharmaceuticals as a Manager, Regulatory Affairs (Clinical Labeling). Focus on IMP labeling for global clinical trials and ensure compliance with regulatory standards.

As a key player in Telix's regulatory framework, you will oversee the lifecycle of Investigational Medicinal Product (IMP) labeling, collaborating with internal and external teams. Your expertise in global regulations will guide the development and maintenance of labeling documentation, supporting clinical study executions worldwide.

Key Responsibilities:

• Lead development and revisions of IMP labeling

• Collaborate with internal and external stakeholders

• Ensure label content meets protocol and regulatory standards

• Manage compliance with GMPs and GCPs

• Coordinate translation and artwork approval processes

Requirements:

• Bachelor’s in life sciences

• 5+ years in pharmaceutical regulatory affairs

• 2+ years in IMP clinical labeling

• Strong knowledge of GMP, GCP, FDA regulations

• Proficiency in Microsoft Office and labeling systems

Bring your regulatory expertise and commitment to quality in supporting Telix's mission in precision medicine.