Meitheal Pharmaceuticals, Inc. · 2 weeks ago
Senior Associate Regulatory Affairs - Labeling
Chicago, IL
Full-time
Hybrid
Mid, Senior Level
$70K/yr - $85K/yr
4+ years expMeitheal Pharmaceuticals, Inc. is focused on the development and commercialization of generic injectable medications and has expanded its focus to include fertility and biologic products. The Senior Associate of Regulatory Affairs, Labeling, is responsible for supporting the Labeling function in compliance with FDA regulations, including the creation and maintenance of labeling files and ensuring quality standards are met.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
Performs daily labeling functions in Regulatory Affairs which includes creation of draft labeling, revision of current labels and/or FDA deficiency letters
Creation and maintenance of all SPL (Structured Product Labeling) and PLR (Physicians Labeling Rule) files to ensure accurate rendering for all products
Makes strategic and critical decisions regarding patents, carve-outs and labeling content
Assesses labeling processes and practices for efficiency and continual improvement
Format/develop labeling annotations and deficiency responses
Meet deadlines and goals in a timely manner
Proofreading and annotating label copy to the highest quality standards
Ability to document changes and justification by developing and creating change controls
Qualification
Required
Bachelor's degree in life sciences from a 4-year college or university
Over 4 years related experience and/or training
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 general 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
Adobe Systems (Pro, Acrobat DC and Illustrator)
Microsoft Office
DocuProof
Barcode Studio
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