Senior Associate Regulatory Affairs - Labeling

Senior Associate of Regulatory Affairs, Labeling

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.

Position 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.

Payrate is determined by considering a person's prior experience and competence.

Why Work with Us?

* 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.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

* 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.

Education and/or Experience

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.

Language Skills

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.

Reasoning Ability

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.

Travel

N/A

Computer skills

Adobe Systems (Pro, Acrobat DC and Illustrator), Microsoft Office, DocuProof, Barcode Studio

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.