CMC Regulatory Submissions Specialist

Regeneron Pharmaceuticals, Inc.; United States; Remote; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Regeneron Pharmaceuticals, Inc. is seeking a regulatory professional to provide Chemistry, Manufacturing, and Controls (CMC) support across its sites.

You will prepare global CMC documents for clinical and commercial submissions, ensuring accuracy and compliance with FDA and ICH guidelines. In this role you will manage authoring, review, and finalization of CMC submissions, coordinate with cross-functional teams and external partners, and help develop regulatory strategies.

Qualifikationen

• BA/BS degree or equivalent is required.
• Degree in a scientific field preferred.
• Advanced degree preferred.

Aufgaben

• Prepare global CMC documents for regulatory submissions.
• Coordinate authoring, review, and finalization of CMC documents.
• Collaborate with cross-functional teams and external partners.
• Identify issues and contribute to risk mitigation strategies.
• Prepare for meetings with global regulatory authorities.

Jobbeschreibung

Regeneron Pharmaceuticals, Inc. is seeking a regulatory professional to provide Chemistry, Manufacturing, and Controls (CMC) support across its sites.

You will prepare global CMC documents for clinical and commercial submissions, ensuring accuracy and compliance with FDA and ICH guidelines. In this role you will manage authoring, review, and finalization of CMC submissions, coordinate with cross-functional teams and external partners, and help develop regulatory strategies.