Manager, Regulatory Affairs (Clinical Labeling)

About the role

The Manager, Regulatory Affairs (Clinical Labeling) will lead the development, maintenance and oversight of Investigational Medicinal Product (IMP) labeling for Telix’s investigational products used in global clinical trials. This role ensures compliance with global regulatory requirements, GMP, GCP and company standards while supporting study timelines.

Key responsibilities

• Lead creation, revision, review and maintenance of IMP labeling and calibration labeling across multiple regions.
• Collaborate with internal teams (Regulatory Affairs, Clinical Operations, Quality) and external partners (CROs, CMOs, translation and artwork vendors) to obtain input, review and approval of labeling.
• Ensure label content reflects protocol requirements, product characteristics, storage conditions and country‑specific regulations.
• Coordinate translation, artwork approval and version control for multilingual labeling.
• Provide labeling expertise during protocol development, study start‑up, amendments and country expansions.
• Support regulatory submissions, inspections and audits related to IMP labeling.

Required profile

• Bachelor’s degree in life sciences.
• Minimum 5 years of experience in pharmaceutical regulatory affairs or clinical labeling, including at least 2 years focused on IMP labeling.
• Demonstrated experience supporting IMP labeling for clinical trials across multiple regulatory jurisdictions.
• Strong knowledge of GMP, GCP, EU Clinical Trial Regulation, Annex VI, Annex 13 and FDA IMP requirements.

Required skills

• Proficiency with Microsoft Office applications.
• Experience with labeling management systems; working knowledge of Veeva is desired.

What we offer

• Competitive salary and annual performance‑based bonus.
• Equity‑based incentive program.
• Generous vacation, paid wellness days and support for learning and development.
• Hybrid and remote work options within a global, interdisciplinary team.