Senior Manager Regulatory Affairs US Advertising and Promotion - Immunology - Dermatology

Allergan; Greenlawn (NY); On-site; USD 80,000 - 130,000; Full time

Job summary

An established industry player is seeking a Senior Manager of Regulatory Affairs to lead and mentor a team in the Immunology-Dermatology sector. This role combines scientific and regulatory expertise to ensure compliance with advertising and promotion regulations. The successful candidate will monitor regulatory changes, represent the department in trade associations, and develop strategies for promotional activities. This position offers a unique opportunity to impact the regulatory landscape while working collaboratively with cross-functional teams. Join a forward-thinking company dedicated to innovation and excellence in healthcare.

Qualifications

• 7+ years of relevant industry experience in Regulatory Affairs.
• Experience in complex, matrix environments with strong negotiation skills.

Responsibilities

• Monitor updates from government and industry affecting pharmaceutical regulations.
• Oversee regulatory staff for advertising and promotion materials.
• Develop strategies for promotional activities across therapeutic areas.

Skills

Regulatory Affairs

Communication Skills

Negotiation Skills

Team Management

Education

Bachelor’s degree in Science

PharmD degree

Job description

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn, and TikTok.

Job Description

The Senior Manager of Regulatory Affairs US Advertising and Promotion in Immunology-Dermatology combines scientific, regulatory, and business expertise to ensure that products meet all required legislation. The role involves developing and supervising regulatory professionals, supporting efforts to influence the regulatory environment, and serving as a subject matter expert (SME) in Regulatory. The individual shares knowledge with team members and analyzes the implications of regulatory changes.

Responsibilities include:

1. Monitoring and communicating updates from government, industry, and trade associations affecting pharmaceutical regulations; drafting and sharing comments and policy summaries.
2. Representing the department in trade associations and developing relationships with trade managers.
3. Preparing concise reports on regulatory findings for internal distribution.
4. Overseeing regulatory staff responsible for advertising and promotion materials to ensure accuracy, competitiveness, and compliance with CFR, FDA guidance, PhRMA principles, and the FDA and Cosmetic Acts.
5. Developing strategies for promotional activities and applying broad regulatory/technical knowledge across therapeutic areas.
6. Ensuring departmental training and compliance with regulations, SOPs, and promotional guidelines; managing and mentoring staff.
7. Presenting information effectively to cross-functional teams and managing difficult communications with commercial groups.
8. Building strong relationships with management and stakeholders across Marketing, Medical, Legal, Sales, and other departments.

Significant Work Activities:

Prolonged sitting (more than 2 hours in an 8-hour day) is required.

Qualifications

• Minimum: Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, nursing) plus 7 years of relevant industry experience.
• Preferred: PharmD degree plus 5 years of relevant experience.
• Experience in complex, matrix environments with strong negotiation skills.
• Excellent communication skills, both oral and written.
• Management experience preferred.
• Experience in US Regulatory Affairs Advertising and Promotion preferred.

Additional Information

Includes pay disclosure details as per applicable laws, benefits, and participation in incentive programs. All compensation details are at the company's discretion and subject to change.

AbbVie is an equal opportunity employer committed to integrity, innovation, and community service. For more details, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html and https://www.abbvie.com/join-us/reasonable-accommodations.html.