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Regeneron Pharmaceuticals

Develops biopharmaceutical therapies for serious diseases

Director Regulatory Affairs - Advertising & Promotion

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeRemote in USA$205k - $341.6k /yr

About the Job

Requirements

  • A Master's, PharmD, or PhD, or a Bachelor's degree in Life Sciences from an accredited institution.
  • At least 7 years of biotechnology or pharmaceutical industry experience.
  • Deep expertise in advertising and promotion regulations, guidance, and development precedents.
  • Experience supporting pharmaceutical products; biologics experience is a plus.
  • Experience working directly with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotional Labeling Branch (APLB).
  • Experience reviewing promotional materials and supporting product launches or campaigns.
  • Knowledge of commercialization strategy, labeling development, and marketing application content.
  • Experience leading teams, influencing cross-functional stakeholders, and working with senior management.
  • Strong written and verbal communication skills for providing strategic regulatory guidance.

Responsibilities

  • Lead U.S. and global regulatory activities supporting advertising, promotion, and commercialization initiatives.
  • Advise on product messaging and promotional materials across functional areas.
  • Provide regulatory guidance for conference exhibits, disease awareness, and speaker programs.
  • Review promotional and disease-state communications for compliance with applicable requirements.
  • Partner with Marketing, Medical Affairs, Legal, and Regulatory Therapeutic Area Leads.
  • Oversee FDA promotional interactions, advisory submissions, and Form 2253 compliance.
  • Drive process improvements and portfolio-wide promotional policy standardization.
  • Build trusted relationships that influence decisions across complex stakeholder groups.

Desired Qualifications

  • Experience with global promotional review, clinical trial recruitment materials, and labeling regulations.

About the Company

Regeneron Pharmaceuticals

Develops biopharmaceutical therapies for serious diseases

Regeneron Pharmaceuticals develops and commercializes medicines for serious diseases, with a focus on cancer, eye diseases, allergic and inflammatory diseases, and infectious diseases. Its products come from using proprietary research capabilities and technologies to discover and develop therapies, often in collaboration with academic, research, and industry partners. Revenue comes from selling approved medicines and from licensing its technologies and entering co-development and co-commercialization partnerships. The company works with healthcare providers and regulators to ensure treatment delivery and safety. Its goal is to improve patient outcomes by bringing life-transforming medicines to market through rigorous R&D and strategic collaborations, maintaining leadership in biopharmaceutical innovation.

Company size
10,001+
Company stage
IPO
Headquarters
Town of Mount Pleasant, New York
Founded
1988

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