Regulatory Affairs Manager

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 Regulatory Affairs Manager (CMC) position is responsible for the author, review, preparation and manage on-time filing of high-quality regulatory submissions and for post-approval maintenance of regulatory dossiers with an emphasis on CMC.

The pay range for this position is: $85,000 - $115,000.

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.

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.

* The primary responsibility will include authoring, reviewing and preparing high quality ANDA, NDA, BLA, IND and DMF submissions.

* Prepare, review and submit responses to FDA's CRLs, DRLs and Information Requests within predetermined and negotiated deadlines.

* Review and submit post-approval supplements, safety update reports to INDs, NDAs, ANDAs and BLAs.

* Participate in development and commercial team meetings representing RA CMC.

* Review and approve change controls from global manufacturing partners

* Experienced with FDA's eCTD requirements for Modules 1-5.

* Work in a collaborative environment with cross-functional teams, not limited to Labeling, R&D, Manufacturing, Medical Affairs, Operations, Marketing and Quality.

* Adhere to submission timelines as per the internal tracking. Administration and management of assigned products. Perform other duties as assigned by the Supervisor.

* Maintains current knowledge of regulations. Serves as the primary regulatory interface with US FDA manufacturing partners (domestic and international), and internal teams to ensure the business needs for the assigned products are met by anticipating, identifying, prioritizing and mitigating regulatory risks while following all regulatory requirements.

* Support Biosimilar BLA/PAS/CBE submissions, as assigned.

Competencies

* Planning and Organizing

* Communication

* Strategic Thinking

* 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.

* Assimilate to changing environments.

* Ability to prioritize and multitask.

* Organized and detailed orientated.

* Have a sense of urgency to meet all required deadlines

Education and/or Experience:

* Bachelor's degree in life sciences from a 4-year college or university with 5 or more years of direct experience in Regulatory Affairs within bio/pharmaceutical companies, with focus in CMC. Candidates with additional prior experience in R&D or Manufacturing will be a plus.

* Excellent attention to details, technical writing, organizational and communication skills.

* Ability to prioritize and handle multiple projects concurrently.

* Familiar with 21 CFR, FDA and ICH.

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.