Manager, Regulatory Affairs (Ad-Promo)

Role: Manager, Regulatory Affairs (Ad-Promo) at Telix Pharmaceuticals, focusing on strategic and operational regulatory review of advertising and promotional materials for investigational and approved products across global markets. Responsibilities: review and ensure compliance of promotional, disease awareness, and training materials; manage regulatory submissions for promotional activities, including Form FDA 2253 in the U.S.; serve as the Regulatory Representative on the Materials Review Committee; monitor evolving regulatory guidance, especially in the U.S.; collaborate with cross-functional teams (Medical Affairs, Legal, Marketing) and external vendors; support regional affiliates with regulatory interpretation; and improve review processes. Qualifications: Bachelor's in life sciences, law, or related field, with at least 5 years’ pharma regulatory experience, including 2+ years in advertising/promotion review; familiarity with U.S. FDA regulations, regional codes, and submission processes; experience with Veeva PromoMats preferred; strong communication, collaboration, and ethical standards. High-Value: radiopharmaceuticals, oncology (prostate cancer imaging agent), global regulatory review, U.S. FDA, Form FDA 2253, international markets (Europe, Australia, North America); GxP familiarity. WorkSetup: hybrid/remote with global stakeholder engagement; no specific travel mentioned.