Senior Manager, Regulatory Affairs Advertising and Promotions

Senior Manager, Regulatory Affairs Advertising and Promotions

4 days ago Be among the first 25 applicants

About Us
Founded in 2017 and based in Chicago, Meitheal focuses on the development and commercialization of generic injectable medications and, since 2022, fertility, biologic, and branded products. We market over 60 FDA-approved products across anti‑infectives, oncolytics, intensive care, and fertility. Our mission is to provide easy access to fairly priced products through robust manufacturing and consistent supply.

Job Type
Full‑time

Position Summary
The Senior Manager of Regulatory Affairs, Advertising and Promotions coordinates the medical, legal, and regulatory (MLR) review of promotional and informational materials for our branded, generic, and biosimilar products in the U.S., ensuring compliance with FDA requirements and company policies. They lead the cross‑functional MLR team, track submissions, maintain documentation, and serve as subject‑matter expert for regulatory insights.

Why Work with Us

• Hybrid work schedule: remote three days per week.
• Casual dress code.
• Collaborative culture with open communication.
• Professional growth opportunities.

Essential Duties and Responsibilities

• Manage end‑to‑end MLR process for promotional materials, ensuring regulatory compliance and company policy approval.
• Establish strong working relationships with cross‑functional and external review teams.
• Maintain effective communication with Marketing, Corporate Strategy, Medical Affairs, Legal, Compliance, and external partners.
• Make regulatory decisions and elevate complex matters to upper management as needed.
• Approve FDA submissions for advertising and promotions, such as Form 2253.
• Work closely with labeling group to update promotional prescribing information and ISI.
• Maintain accurate records of submissions, approvals, comments, and version control.
• Identify process bottlenecks and develop best‑practice playbooks.
• Proactively capture and disseminate activities from government, industry, and trade associations.
• Perform additional duties as assigned.

Competencies

• Regulatory knowledge of advertising and promotion
• Project management
• Change management
• Communication
• Ethics
• Teamwork
• Problem solving
• Judgement
• Dependability
• Strong interpersonal skills

Qualifications

• Bachelor’s degree in life sciences or related field; over six years of regulatory or medical affairs experience.
• Regulatory experience in advertising and promotion strongly preferred.
• Ability to read, interpret, and present regulatory information.
• Strong written and oral communication skills.

Equal Opportunity Employer
Meitheal Pharmaceuticals is an Equal Opportunity Employer. We welcome and encourage applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities.

Salary: $115,000 to $150,000