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Meitheal Pharmaceuticals, Inc. · 16 hours ago

Regulatory Affairs Manager

Chicago, IL

Full-time

Hybrid

Mid, Senior Level

$85K/yr - $115K/yr

5+ years exp

Meitheal Pharmaceuticals, Inc. is focused on the development and commercialization of generic injectable medications and has expanded its focus to include fertility, biologic, and branded products. The Regulatory Affairs Manager (CMC) position is responsible for the authoring, review, preparation, and management of high-quality regulatory submissions and post-approval maintenance of regulatory dossiers with an emphasis on CMC.

BiotechnologyHealth CareManufacturingMedicalPharmaceutical

Responsibilities

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