Associate, Regulatory Affairs - Labeling

Description

ABOUT MEITHEAL PHARMACEUTICALS

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 75 U.S. FDA-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of April 2026, Meitheal, directly or through its partners, has 32 products in the research and development phase, 9 products planned for launch in 2026, 4 products in clinical trial phases, and 13 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 regularly as one of Crain’s Fast 50 in Chicago, and in the top 100 of Crain’s Best Places to Work in Chicago from 2022 to 2025, Meitheal emulates the traditional Irish guiding principle we are named for—working together toward a common goal, for the greater good.

Learn more about who we are and what we do at www.meithealpharma.com.

The pay range for this position is $70,000 to $80,000 / year. Payrate is determined by considering a person's prior experience and competence.

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

What We Offer

• Competitive pay and medical, dental, and vision insurance
• Flexible spending accounts
• Long- and short-term disability insurance, as well as life insurance
• 401(k) plan with match
• Competitive PTO and company-paid holidays
• Paid parental leave (maternity & paternity)
• Employee assistance program
• Onsite gym
• Hybrid work schedule

Summary

The Senior Associate of Regulatory Affairs, Labeling, is responsible for providing effective support to the Labeling function in Regulatory Affairs, in compliance with the FDA regulations, 21 CFR Part 201 and internal labeling policies and/or procedures.

Essential Responsibilities

Essential Duties and Responsibilities include the following:

• 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.

Competencies

• Planning and Organizing
• Teamwork
• Problem Solving
• Quality
• Judgement
• Dependability

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• 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.
• The ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Education and/or Experience Required

• Bachelor's degree in life sciences from a 4-year college or university; over 4 years related experience and/or training; or equivalent combination of education and experience.

Computer Skills

• Microsoft Word, PowerPoint and Excel.
• Adobe Systems (Pro, Acrobat DC and Illustrator), Microsoft Office, DocuProof, Barcode Studio).

Physical Demands

• While performing the duties of this Job, the employee is frequently required to stand; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 20 pounds.

Work Environment

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The noise level in the work environment is usually moderate.

AAP/EEO

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