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Manager, Regulatory Affairs (Ad-Promo)

10 hours, 36 minutes ago
United States
Full-time
Senior
Compliance Manager
Legal
Apply Now
Telix Pharmaceuticals

Telix Pharmaceuticals

Telix Pharmaceuticals is a global biopharmaceutical firm dedicated to the development and commercialization of diagnostic and therapeutic products that utilize targeted radiation, aiming to enhance treatment decisions and provide personalized therapies...

Pharmaceuticals
201-500
Founded 2015
View All Jobs 31

Description

  • Review promotional, non-promotional, disease-awareness, training, and campaign materials for compliance with applicable regulations and company policies.
  • Represent Regulatory Affairs on the Materials Review Committee and advise Medical Affairs, Legal, and Marketing on regulatory risk.
  • Manage advertising and promotion regulatory activities for assigned products across U.S. and international markets.
  • Coordinate health authority submissions for promotional materials, including U.S. Form FDA 2253 submissions.
  • Monitor FDA guidance, enforcement actions, and industry trends and communicate relevant developments to stakeholders.
  • Create, maintain, and archive abbreviated Prescribing Information in line with regulatory requirements.
  • Serve as the regulatory contact for global, regional, and local brand teams.
  • Ensure ex-U.S. materials align with local prescribing information, country-specific codes, and global standards following labeling updates.
  • Support affiliates in applying national and regional promotional codes and developing compliant communication approaches.
  • Coordinate external review vendors and improve global review workflows, templates, checklists, and processes.

Requirements

  • Bachelor’s degree in life sciences, law, public policy, or a related field.
  • Master’s degree or higher preferred.
  • Minimum 5 years of pharmaceutical regulatory affairs experience, including at least 2 years in regulatory advertising and promotion.
  • Experience reviewing U.S. advertising and promotional materials and completing Form FDA 2253 submissions.
  • In-depth knowledge of international, national, and regional regulatory frameworks and requirements.
  • Working knowledge of FDA regulations and OPDP guidance for radiopharmaceutical advertising and promotion.
  • Knowledge of promotional codes such as EFPIA, ABPI, Farmaindustria, AKG, and IFPMA.
  • Experience with Veeva PromoMats is desired.
  • Strong communication, collaboration, adaptability, ethical judgment, and continuous-learning mindset.

Benefits

  • Competitive salary.
  • Annual performance-based bonus.
  • Equity-based incentive program.
  • Generous vacation and paid wellness days.
  • Learning and development support.
  • Hybrid and remote work opportunities.

Interested in this position?

Apply directly on the company website

Apply Now

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