Head of Regulatory Affairs for Advertising

1 week ago

Foster City, California, United States Milestone Technologies, Inc. Full time

Position Overview

The Senior Director of Regulatory Affairs for Advertising & Promotion will lead, guide, and provide strategic direction on all advertising and promotional initiatives, ensuring adherence to regulations, alignment with approved product registrations, and compliance with company policies throughout the product lifecycle. This role will collaborate with various Regulatory Affairs divisions, Medical Affairs, Legal, Compliance, and Commercial/International partners, serving as a vital member of the Medical/Legal/Regulatory (MLR) Review Committee. Reporting to the Executive Director of Commercial Regulatory Affairs & Labeling, this position is critical for maintaining regulatory integrity.

Key Responsibilities

  • Lead regulatory advertising and promotion efforts for assigned marketed and investigational products across US and international markets.
  • Oversee the review and approval process of advertising and promotional materials as the primary regulatory reviewer on the MLR Committee.
  • Act as the main regulatory contact for FDA/CDER/OPDP.
  • Prepare regulatory submissions (Form 2253) and coordinate with publishing vendors to ensure timely submission of promotional materials to the Office of Prescription Drug Promotion (OPDP).
  • Represent Regulatory Affairs Advertising/Promotion in labeling discussions, providing informed strategic regulatory insights.
  • Offer regulatory guidance on new promotional initiatives or disease awareness campaigns related to company products.
  • Stay informed about FDA and international health authority regulations, guidance documents, and enforcement actions concerning advertising and promotion of pharmaceutical products. Monitor enforcement trends and provide timely updates to the team.
  • Serve as a knowledgeable resource for regulatory advertising and promotion across various departments.
  • Contribute to enhancements in commercial regulatory processes, including the MLR Committee.
  • Develop and implement regulatory advertising and promotional processes as necessary.
  • Assist with product labeling activities as required.

Qualifications

  • 10+ years of experience in the biopharmaceutical sector, with a minimum of 8 years in the regulatory review of advertising and promotional materials for prescription drugs and/or biologics.
  • Proven experience representing Regulatory Affairs Advertising/Promotion on cross-functional teams.
  • Strong planning and organizational skills with the ability to manage multiple projects under tight deadlines.
  • Exceptional verbal and written communication skills.

Education

  • Bachelor's degree in a biological, life sciences, or related scientific field (pharmacy, medicine, etc.); an advanced degree is preferred.

Knowledge, Skills, and Abilities

  • Direct experience with FDA's Office of Prescription Drug Promotion (OPDP) submissions and strategies; familiarity with international health authorities is a plus.
  • Comprehensive knowledge of regulatory requirements associated with advertising and promotion of prescription drug products, with demonstrated application of these requirements.
  • Experience with Veeva Vault RIM and QualityDocs is advantageous.
  • Familiarity with global regulations regarding the promotion of medical products is highly desirable.
  • Strong verbal, written, negotiation, influence, and interpersonal communication skills are essential.
  • Ability to critically evaluate complex technical/scientific documents and influence colleagues across various functions. Strong analytical skills to interpret efficacy and safety data are crucial.
  • Must be capable of working independently and collaboratively, setting priorities to meet deadlines, and motivating others. A proactive and self-directed approach is required.
  • Ability to engage multiple stakeholders to achieve business objectives while fostering excellent working relationships.
  • A strong team player with a customer service mindset and a solution-oriented approach.

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