About Meitheal Pharmaceuticals

Founded in 2017 and headquartered in Chicago, Meitheal Pharmaceuticals is a leading provider in the development and commercialization of generic injectables, fertility, biologics, and biosimilars. With a commitment to providing affordable and accessible healthcare solutions, Meitheal markets over 50 FDA-approved products across multiple therapeutic areas. Our mission is to work collaboratively towards a common goal, for the greater good. Ranked among the top 100 Crain's Best Places to Work in Chicago, Meitheal embraces the guiding principle of Meitheal-working together towards a common goal.

Position Summary

The Regulatory Affairs CMC Manager / Sr. Manager is responsible for the on-time filing of high-quality regulatory submissions and for the post-approval maintenance of regulatory dossiers with an emphasis on CMC. This role provides regulatory guidance to team members, both internally and externally. The Manager / Senior Manager serves as the primary liaison regarding submissions and other relevant topics.

Essential Duties and Responsibilities

• Serve as the primary regulatory interface with US FDA manufacturing partners (domestic and international), and internal teams to ensure business needs for the assigned products are met by anticipating, identifying, prioritizing, and mitigating regulatory risks while complying with all regulatory requirements.
• Develop and oversee the CMC regulatory strategy, preparation, and review of US FDA submissions, including original BLAs, 505B(2)/NDAs, ANDAs, amendments, supplements, annual reports, and labeling changes to BLAs, NDAs, and ANDAs.
• Individually perform and manage projects during all stages of the drug approval process to post-approval/life cycle management, collaborating with project management, business development, and legal to ensure the regulatory strategy aligns with corporate needs.
• Perform reviews of documentation from partners (domestic and international) for technical and regulatory compliance with minimal supervision.
• Approve manufacturing and labeling change controls, ensuring compliance with US regulations and guidelines.
• Train and mentor Regulatory Affairs associates on CMC product development and post-approval changes.
• Represent the Regulatory Affairs department in project development meetings and assist in developing regulatory strategies.
• Manage multiple projects within negotiated deadlines.
• Provide regulatory assessments to company (internal and partners) change controls and/or document changes based on ICH and FDA guidelines.

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.

• Adapt to changing environments.
• Ability to prioritize and multitask.
• Organized and detail oriented.
• 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; a minimum of 4 years related experience and/or training; or equivalent combination of education and experience.
• Experience in Pharmaceutical R&D and/or Manufacturing setting with some exposure to Regulatory Affairs is highly preferred. Experience with complex generics, drug-device combination products, biosimilars, or biologics is a plus!
• Strong written and communication skills.
• Experience communicating with global teams is preferred.
• Ability to handle multiple projects concurrently.

Computer Skills

• Proficient in Microsoft Office, Adobe Systems (Pro, Acrobat DC), Regulatory publishing systems (DocuBridge), and Quality management systems (TrackWise).

AAP/EEO Statement

Meitheal Pharmaceuticals is an Equal Opportunity Employer. We encourage applications from Minorities, Women, Veterans, and individuals with disabilities.

Apply Now

Join our team at Meitheal Pharmaceuticals and contribute to our mission of providing affordable and accessible healthcare solutions. Apply today to be a part of our collaborative and innovative work environment!