Senior Associate, Regulatory Affairs - CMC

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 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 2025, Meitheal emulates the traditional Irish guiding principle we are named for — working together toward a common goal, for the greater good.

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 employer contribution
• Competitive PTO and company-paid holidays
• Paid parental leave (maternity & paternity)
• Onsite gym
• Hybrid work schedule

The estimated salary range reflects an anticipated range for this position of $70,000 to $85,000 / year.

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.

Position Summary

The Senior Regulatory Affairs Associate (CMC) position is responsible for the on-time filing of high-quality regulatory submissions and for post-approval maintenance of regulatory dossiers with an emphasis on CMC. 

Essential Duties and Responsibilities  

Essential Duties and Responsibilities include the following: 

• Supports life cycle management of approved products. Preparation and review of ANDAs, NDAs, annual reports, periodic adverse events reports, supplements, amendments, control correspondences etc.
• Reviews and management of regulatory submissions to FDA from international partners and CMOs for technical and regulatory compliance.
• Review and approve CMC and Labeling change controls from global R&D, QC, manufacturing sites and CMOs. 
• Familiar with FDA requirements and ICH.
• Adhere to submission timelines as per the internal tracking. Administration and management of assigned products. Perform other duties as assigned by the Supervisor.
• 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.
• Maintains sound knowledge of regulations, policies/guidelines and keep abreast with evolving regulatory CMC requirements. 
• Other duties may be 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 preferred, or equivalent experience required.
• 5 or more years of recent pharma / biotech / life sciences industry experience in a related function (Regulatory Affairs, R&D, Quality, Manufacturing) preferred.
• Strong written and communication skills.
• Ability to handle multiple projects concurrently.
• Familiar with 21 CFR, FDA and ICH.

Computer Skills

MS Office proficiency (Excel, Word, PowerPoint) 

AAP/EEO Statement

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

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