Manager, Regulatory Affairs – Ad-Promo

🕒 September 28

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 14%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Open for 45 days.
• Jobs at this company usually fill in 35 days.
• No salary listed.

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Telix Pharmaceuticals Limited

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2015

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Telix Pharmaceuticals Limited is a commercial-stage biopharmaceutical company dedicated to transforming the way cancer and rare diseases are diagnosed and treated. Focusing on the development and commercialization of theranostic radiopharmaceuticals, Telix utilizes targeted radiation to enhance treatment decision-making and deliver personalized therapy. With an extensive pipeline addressing areas such as prostate and kidney cancer, neuro-oncology, and musculoskeletal cancers, Telix has garnered global regulatory approvals for its lead imaging agent, Illuccix®, and is actively conducting numerous clinical trials worldwide.

📋 Description

• 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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