Senior Associate Regulatory Affairs -Publishing

About Meitheal

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 brand products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytic, 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 in2024 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 Senior Associate is responsible for providing effective support to the Publishing Operations function in Regulatory Affairs. The responsibilities for this position include utilizing publishing systems and processes for the preparation of high-quality submission dossiers, ensuring compliance with the FDA regulations and internal policies/procedures. Pharmaceutical experience required.

The estimated salary range reflects an anticipated range for this position of $70,000 to $90,000. 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.

Essential Duties and Responsibilities

• Prepare, compile, publish, validate, and submit electronic regulatory submissions (eCTD) for ANDA, NDA, BLA, IND, and DMF applications.
• Manage pre-approval, post-approval, and lifecycle management submissions, including Annual Reports, PADERs, PAS, CBE-0, CBE-30, Amendments, Supplements, and Safety Reports.
• Publish and submit Promotional and Advertising materials in compliance with FDA OPDP/2253 requirements.
• Perform advanced quality control (QC) reviews of submission components, including XML backbone, metadata, hyperlinks, bookmarks, file naming conventions, and validation reports.
• Submit eCTD submissions through the ESG FDA gateway, ensuring all components meet eCTD format requirements in collaboration with the publishing operations lead.
• Handle ANDA, NDA, and BLA submissions for pre-approval, post-approval, and promotional materials, supporting full product lifecycle management.
• Develop and maintain an in-depth understanding of relevant US and EU regulatory requirements for submissions.
• Troubleshoot and resolve complex technical issues related to publishing systems, validation errors, gateway rejections, large file handling, and system performance.
• Perform administrative tasks related to submissions, including transferring files via FTP servers.
• Input submission information into internal databases and systems per company procedures.
• Perform other duties as assigned to support Regulatory Affairs publishing operations.

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 accommodations 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 Required

Bachelor's degree from a 4-year college or university; over 3-4 years pharma experience and/or training; or equivalent combination of education and experience.

Computer Skills

Excellent dexterity: Microsoft Office (Word, Excel, Power Point and Outlook), Adobe Systems (Pro, Acrobat DC), and Practice Database system (DocuBridge, Veeva Systems, eCTD Manager, Liquent Insight publisher, etc).

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 10 pounds.

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.