Hybrid Senior Manager, Regulatory Affairs – Ads & Promotion

BioSpace; Irvine (CA); Hybrid; USD 150,000 - 190,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie in Irvine, CA is seeking a Senior Manager Regulatory Affairs US Advertising and Promotion-Immunology to lead regulatory strategy for immunology products. You will supervise regulatory professionals and coordinate with Marketing, Legal, Medical, and other functions to ensure compliant advertising and promotion.

This role requires deep knowledge of CFR, FDA guidelines, and PhRMA principles; you will influence policy, mentor staff, and manage a hybrid work schedule (3 days in office, 2

Qualifications

• Bachelor's degree in science plus 7 years relevant industry experience
• PharmD degree plus 5 years relevant industry experience
• Experience in a complex matrix environment with negotiation skills
• Strong communication skills, oral and written
• Management experience preferred
• Experience in US Regulatory Affairs Advertising and Promotion

Responsibilities

• Captures and disseminates regulatory policy developments impacting AbbVie's interests and communicates impact within Regulatory Operations
• Represents department and engages with trade associations as needed
• Summarizes findings in concise reports for distribution within AbbVie's regulatory function
• Oversee operations productivity and development of regulatory staff for advertising and promotion compliance with CFR, FDA guidance, PhRMA, and related acts
• Develops and guides implementation strategies for promotional activities
• Broadly applies regulatory/technical knowledge across therapeutic areas
• Ensures training and compliance with regulations, SOPs, and guidelines; manages reports
• Presents pertinent information to cross-functional groups
• Establishes strong relationships with stakeholders across Marketing, Medical, Legal, Sales Training, etc.
• Hybrid work schedule (3 days in office & 2 days remotely) from Irvine, CA

Skills

Strong communication skills

Negotiation skills

Management experience

US Regulatory Affairs Advertising and

Education

Bachelor's degree in science

PharmD preferred

Job description

AbbVie in Irvine, CA is seeking a Senior Manager Regulatory Affairs US Advertising and Promotion-Immunology to lead regulatory strategy for immunology products. You will supervise regulatory professionals and coordinate with Marketing, Legal, Medical, and other functions to ensure compliant advertising and promotion.

This role requires deep knowledge of CFR, FDA guidelines, and PhRMA principles; you will influence policy, mentor staff, and manage a hybrid work schedule (3 days in office, 2