Regulatory Affairs Leader - US Advertising & Promotion

BioSpace

Irvine (CA)

Hybrid

USD 140,000 - 210,000

Full time

2 days ago
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Benefits offered by this job

Benefits package

Job summary

AbbVie in Irvine, CA is seeking a Senior Manager Regulatory Affairs US Advertising and Promotion to lead regulatory strategy for advertising and promotion activities across products. You will supervise regulatory professionals, influence policy, and ensure compliance with CFR, FDA guidelines, PhRMA principles, and related acts.

The role requires strong negotiation and communication skills, experience in a complex matrix environment, and the ability to collaborate across Marketing, Legal,

Qualifications

  • Bachelor's degree in science plus 7 years of relevant industry experience (e.g., regulatory affairs, Health Authority, ad promo).
  • PharmD degree plus 5 years of relevant industry experience.
  • Experience in US Regulatory Affairs Advertising and Promotion.
  • Experience in a complex matrix environment with strong negotiation skills.
  • Strong communication skills and management capacity preferred.

Responsibilities

  • Capture and disseminate activities of government, industry, and trade associations impacting regulatory policies related to AbbVie's interests.
  • Represent department in trade associations and build good working relationships.
  • Summarize findings in concise reports for AbbVie.
  • Oversee operations, productivity and development of regulatory staff responsible for advertising and promotion compliance (CFR, FDA guidance, PhRMA, FDA and cosmetic Act).
  • Develop and guide implementation strategies for promotional activities.
  • Apply regulatory/technical knowledge across therapeutic areas.
  • Ensure training and compliance with regulations, guidance, SOPs related to advertising and promotion.
  • Present pertinent information to cross-functional groups and maintain stakeholder relationships.

Skills

Regulatory affairs
Negotiation skills
Communication skills
Management experience

Education

Bachelor's degree in science
PharmD degree

Job description

AbbVie in Irvine, CA is seeking a Senior Manager Regulatory Affairs US Advertising and Promotion to lead regulatory strategy for advertising and promotion activities across products. You will supervise regulatory professionals, influence policy, and ensure compliance with CFR, FDA guidelines, PhRMA principles, and related acts.

The role requires strong negotiation and communication skills, experience in a complex matrix environment, and the ability to collaborate across Marketing, Legal,

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