Manager, Regulatory Affairs – Ad-Promo
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Job Description
Regulatory Affairs Manager guiding advertising and promotion compliance for Telix’s radiopharmaceutical cancer and rare-disease products. Reviewing global materials, FDA submissions, and regulatory strategies.
Responsibilities:
- Provide strategic, operational, and tactical regulatory advice on advertising and promotion materials for investigational and approved commercial products
- Manage regulatory review of advertising, promotion, disease awareness, training materials, campaigns, and product launch strategies
- Review materials for the U.S., Canada, Australia, the UK, Belgium, the Netherlands, Luxembourg, Spain, Germany, and other ex-U.S. markets
- Participate as Regulatory Representative on the Materials Review Committee with Medical Affairs, Legal, and Marketing
- Coordinate health authority submissions, including U.S. Form FDA 2253 submissions
- Monitor U.S. promotional regulatory developments, FDA regulations, guidance, enforcement actions, and industry trends
- Create, maintain, and store abbreviated Prescribing Information (aPI)
- Serve as regulatory point of contact for global, regional, and local brand teams
- Manage ex-U.S. promotional and non-promotional material reviews across priority global markets
- Support affiliates with national and regional codes including EFPIA, ABPI, Farmaindustria, and AKG/IFPMA
- Coordinate external vendors and maintain standardized global review processes
- Establish cross-functional relationships to enable compliant communication strategies
- Identify process improvements, best practices, and tools for regulatory advertising and promotion activities
Requirements:
- Bachelor's degree in life sciences, law, public policy, or a related field
- Minimum 5 years’ experience in pharmaceutical regulatory affairs, including at least 2 years of experience in regulatory advertising and promotion
- Experience reviewing U.S. advertising and promotion materials and completing Form FDA 2253 for U.S. submissions
- In-depth understanding of relevant international, national, and regional regulatory frameworks, processes, and requirements
- Working knowledge of Veeva PromoMats is desired
- Strong communication skills
- Ability to collaborate effectively with cross-functional stakeholders
- Commitment to ethical behavior
- Adaptability in a dynamic environment
- Commitment to continuous learning and professional development
Benefits:
- Annual performance-based bonuses
- Equity-based incentive program
- Generous vacation
- Paid wellness days
- Support for learning and development
- Competitive salary
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