Senior Regulatory Affairs Leader, US Ad & Promotion

SmartRecruiters, Inc.; Florham Park (NJ); Hybrid; USD 125,000 - 237,000; Full time

Job summary

AbbVie in the United States seeks a Senior Manager Regulatory Affairs US Advertising and Promotion to blend scientific, regulatory, and business expertise and to lead regulatory professionals as SME. The role supports the Director and influences the regulatory environment across products developed, manufactured or distributed by AbbVie.

The position responsibilities include coordinating regulatory policy activities, drafting comments, and presenting findings to cross-functional groups.

Qualifications

• Bachelor’s degree in science plus 7 years in regulatory affairs.
• PharmD degree plus 5 years preferred.
• Experience in complex, matrix environments and strong negotiation skills.

Responsibilities

• Proactively captures and disseminates government, industry, and trade association activities impacting regulatory policies; drafts and finalizes comments for regulators and SMEs.
• Represents department and builds relationships with trade association managers.
• Summarizes findings in concise reports for distribution within AbbVie.
• Oversees operations productivity and develops regulatory staff; ensures advertising materials are compliant with CFR, FDA guidance, PhRMA principles, and the FDA cosmetics act.
• Develops and guides implementation strategies for promotional activities.
• Applies regulatory knowledge across therapeutic areas.

Skills

Regulatory affairs

Negotiation

Communication

Team management

Education

Bachelor’s degree in science

PharmD degree

Job description

AbbVie in the United States seeks a Senior Manager Regulatory Affairs US Advertising and Promotion to blend scientific, regulatory, and business expertise and to lead regulatory professionals as SME. The role supports the Director and influences the regulatory environment across products developed, manufactured or distributed by AbbVie.

The position responsibilities include coordinating regulatory policy activities, drafting comments, and presenting findings to cross-functional groups.