Senior Manager, Regulatory Affairs Advertising and Promotions

About Us

Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti‑infectives, oncolytics, intensive care, and fertility. As of January 2025, Meitheal, directly or through its partners, has 19 products in the research and development phase, 22 additional products planned for launch in 2025, and 24 products under review by the FDA.

Meitheal's mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers' needs. Ranked #2 in 2024 on Crain's Fast 50 in Chicago, and in the top 100 of Crain's Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for — working together toward a common goal, for the greater good.

The Senior Manager of Regulatory Affairs, Advertising and Promotions is responsible for coordinating the Medical, Legal, and Regulatory Affairs (MLR) review and approval process and performing regulatory review for promotional and informational materials for branded, generic, and biosimilar products of the Company in the US. Provides expertise concerning the FDA's requirements for the promotional materials and safeguards the practices to adhere to the highest quality and regulatory standards.

Utilizes strong organization and communication skills to coordinate cross‑functional teams, track submissions, and maintain documentation. Ensures compliance with internal policies, company guidelines, and external regulatory requirements. Has cross‑functional influence at all levels and leads the department as a subject matter expert (SME) for Regulatory in MLR review. This individual is to share knowledge and expertise with others in support of team activities and analyzes broad scope implications of changing regulations and policies.

• Hybrid
  
  Work Schedule:
  
  Enjoy the flexibility to work remotely three days a week.
• Casual Dress Code: Embrace a relaxed and comfortable dress code that allows you to express your personal style.
• Collaborative Culture: Join a team that values open communication, teamwork, and the exchange of ideas.
• Professional Growth: We offer ample opportunities for professional development and career advancement.

• Manages the end‑to‑end MLR process for submitting, reviewing, and approving promotional materials, ensuring they are compliant with regulations (the Code of Federal Regulations (CFR), FDA guidance, PhRMA Guiding Principles, etc.) and approved company policies and procedures.
• Establishes strong working relationship with cross‑functional review and supporting team members (internal and external), to facilitate feedback and approvals.
• Aligns and maintains effective communication channels with key counterparts, Marketing, Corporate Strategy, Medical Affairs, Legal and Compliance as well as external partners and consultants.
• Makes challenging decisions based upon sound regulatory knowledge or makes appropriate assessment for elevating to upper management for further consideration.
• Approves FDA submission for Advertising and promotions, such as 2253 forms.
• Works closely with RA labeling group regarding label changes and packaging insert changes to ensure the promotional Prescribing information (PI) and ISI (important Safety Information) are updated as appropriate.
• Maintain accurate records of submissions, approvals, comments, and version control for audit purposes.
• Help identify and address bottlenecks in the review process and may contribute to developing playbooks or best practices.
• Identifies areas of improvement in process, policy, develop recommendations and leads initiatives.
• Proactively captures and disseminates activities of government, industry, and trade associations that impact pharmaceutical regulatory policies. Maintains awareness of pending changes to…