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Head of Regulatory Compliance for Marketing Initiatives

2 months ago

New York, New York, United States EPM Scientific Full time

Position: Senior Director of Regulatory Affairs for Advertising and Promotion

Compensation: $220,000 to $245,000

Overview:

A leading global healthcare organization, committed to enhancing the quality of life through innovative healthcare solutions in pharmaceuticals, medical devices, and consumer health products, is seeking a Senior Director of Regulatory Affairs for Advertising and Promotion. This position is integral to the expanding Ad/Promo team, based in New Jersey, and offers a unique opportunity to influence the company’s mission of improving health outcomes.

Key Responsibilities:

  • Evaluating advertising and promotional materials, new marketing campaigns, and launch strategies for designated products to ensure adherence to regulatory standards. Timely and precise assessments are crucial to meet compliance deadlines.
  • Formulating and executing regulatory strategies and solutions to guarantee that all advertising and promotional content aligns with regulatory mandates and corporate policies.
  • Keeping abreast of FDA activities, including enforcement actions and guidance documents, to evaluate their implications for the company’s product offerings.
  • Ensuring that promotional package inserts and critical safety information are revised as required.

Qualifications:

  • A Bachelor’s degree in Life Sciences or a related discipline is mandatory; an advanced degree (MS, MD, PhD, PharmD) is preferred.
  • A minimum of 10 years of experience in the pharmaceutical sector, with at least 4 years focused on the review of advertising and promotional materials for prescription products.
  • Proficient understanding of the NDA and labeling processes for prescription products.
  • Completion of training courses in advertising and promotional review.
  • Excellent interpersonal skills, a collaborative team player, and strong communication abilities.

Benefits Offered:

  • Comprehensive Medical, Dental, and Vision insurance plans.
  • 401(k) retirement plan with matching contributions.
  • Tuition reimbursement programs.
  • Commuter benefits to support travel expenses.