Remote Regulatory affairs Jobs · GMP

• Provide quality oversight of sterile drug product and finished drug product manufacturing, labeling, packaging, and distribution operations.
• Review and approve batch production records, process validation documents, and quality system records such as deviations and change controls.
• Support regulatory agency inspections and author NDA CMC sections to ensure compliance with GMP and GDP standards.

Amylyx Pharmaceuticals is a clinical-stage company focused on treating diseases with high unmet needs, such as post-bariatric hypoglycemia, Wolfram syndrome, and ALS. The company has an experienced team driven by core values of audacity, curiosity, authenticity, engagement, and accountability, fostering a culture of caring.

• Lead all operational and lifecycle management aspects of Regulatory CMC submissions supporting cell therapy development programs.
• Develop and execute global regulatory CMC strategies aligned with program objectives and regulatory requirements.
• Serve as Regulatory CMC lead on cross-functional program teams, providing strategic regulatory guidance for cell therapy development.

BrainChild Bio is a kids-first company focused on developing innovative cell therapies for patients with devastating diseases. We are a small, mission-driven company with a rapidly growing, dynamic environment.

• Provide QA oversight for CMC drug product and device operations, ensuring compliance with global GMP regulations.
• Approve protocols, batch records, and disposition batches for clinical trials in partnership with external vendors.
• Support health authority inspections and regulatory filings, driving continuous improvement in sterile manufacturing.

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases through innovative anti-FcRn therapies. As a growing biopharmaceutical firm, the company fosters a dynamic, entrepreneurial culture with a focus on compliance and patient safety.