Advertising & Promotion Regulatory Manager (Remote)

Regeneron Pharmaceuticals, Inc (USA)

United States

Hybride

USD 129 000 - 210 000

Plein temps

Il y a 6 jours
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Avantages offerts par ce poste

Annual bonuses
Equity awards
401(k) company match
Health and wellness programs
Paid time off

Résumé du poste

Regeneron Pharmaceuticals, Inc. seeks a Manager to lead US regulatory activities for advertising and promotion of our marketed products. You will provide regulatory guidance to Commercial, Medical Affairs, and Legal teams while ensuring compliance with applicable laws and FDA guidance.

The role involves collaboration across functions, managing advisory submissions with the FDA OPDP, and supporting global promotional reviews and labeling discussions to reflect commercialization objectives.

Qualifications

  • Minimum 2 years in regulatory advertising and promotion.
  • Bachelor's degree in Life Sciences; advanced degree preferred.
  • Knowledge of pharma advertising regulations and guidance.
  • Experience with FDA interactions preferred.

Responsabilités

  • Lead US regulatory activities for advertising and promotion of marketed products.
  • Provide regulatory advice to Commercial and Medical teams.
  • Review materials to ensure compliance with laws and guidance.
  • Collaborate with Marketing, Medical Affairs and Legal.
  • Interact with FDA OPDP/APLB and manage advisory submissions.
  • Support global promotional reviews and labeling discussions.

Connaissances

Regulatory affairs expertise
Written/verbal communication
Cross-functional collaboration

Formation

Bachelor's degree in Life Sciences
Advanced scientific degree

Description du poste

Regeneron Pharmaceuticals, Inc. seeks a Manager to lead US regulatory activities for advertising and promotion of our marketed products. You will provide regulatory guidance to Commercial, Medical Affairs, and Legal teams while ensuring compliance with applicable laws and FDA guidance.

The role involves collaboration across functions, managing advisory submissions with the FDA OPDP, and supporting global promotional reviews and labeling discussions to reflect commercialization objectives.

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