Meitheal Pharmaceuticals, Inc. · 4 days ago
Senior Manager, Regulatory Affairs Advertising and Promotions
Chicago, IL
Full-time
Hybrid
Mid, Senior Level
$115K/yr - $150K/yr
6+ years expMeitheal Pharmaceuticals, Inc. is focused on the development and commercialization of generic injectable medications and has expanded its focus to include fertility, biologic, and branded products. The Senior Manager of Regulatory Affairs, Advertising and Promotions is responsible for coordinating the MLR review and approval process for promotional materials and ensuring compliance with FDA regulations and company policies.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
Manages the end-to-end MLR process for submitting (requesting), 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 propriate assessment for elevating to upper management for further consideration
Approve 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 identifies 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 communicate impact and relevance to the relevant teams
Perform all other duties assigned by supervisor
Qualification
Required
Bachelor's degree in life sciences from a 4-year college or university a plus
over 6 years related experience and/or training, or equivalent combination of education and experience in regulatory affairs and/ or medical affairs
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
Ability to write reports, business correspondence, and procedure manuals
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
Preferred
Regulatory experience in Advertising and Promotion is strongly preferred
Benefits
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.
Company
Meitheal Pharmaceuticals, Inc.
Founded in 2017, Meitheal Pharmaceuticals is a privately owned pharmaceutical company focusing on generic injectable products.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$35MKey Investors
JP Morgan
2023-08-22Debt Financing· $35M
Leadership Team
T
Tom Shea
Chief Executive Officer
Keith Robinson
Chief Medical Officer
Recent News
Business Wire
2025-10-21
Company data provided by crunchbase