Biologics CMC Regulatory Manager

Regeneron Pharmaceuticals; Rensselaer (IN); Presencial; USD 108 000 - 176 000; Tempo integral

Resumo da oferta

Regeneron Pharmaceuticals is seeking a Manager, CMC Regulatory Affairs - Biologics to lead regulatory strategy for biologics across development, submissions, and post‑market activities. This on‑site role involves coordinating with Global Regulatory Affairs and CMC teams to ensure compliance and timely submissions.

You will engage with FDA and other authorities, translate complex regulatory requirements into actionable plans, and drive process improvements across the organization.

Qualificações

• Bachelor’s degree with 6+ years in pharmaceutical/biotech or Health Authority settings.
• 2–4 years of CMC Regulatory Affairs experience with worldwide regulations.
• Experience delivering CMC sections of MAAs, CTAs/INDs, and post‑approval submissions.
• Biologics experience and FDA interactions are preferred.

Responsabilidades

• Lead CMC regulatory strategies for assigned biologic products.
• Support CMC development through early phase, submission, and post‑market activities.
• Assess changes and deviations for regulatory impact and filing requirements.
• Review regulatory filings for compliance with regulations and guidelines.
• Support regulatory authority interactions, including meetings and information requests.
• Develop Working Instructions, SOPs, and Reviewer’s Guides to improve consistency.

Conhecimentos

Regulatory strategy

CMC regulatory affairs

Cross‑functional collaboration

Communication

Negotiation

Problem solving

Formação académica

Bachelor's degree

Advanced degree

Descrição da oferta de emprego

Regeneron Pharmaceuticals is seeking a Manager, CMC Regulatory Affairs - Biologics to lead regulatory strategy for biologics across development, submissions, and post‑market activities. This on‑site role involves coordinating with Global Regulatory Affairs and CMC teams to ensure compliance and timely submissions.

You will engage with FDA and other authorities, translate complex regulatory requirements into actionable plans, and drive process improvements across the organization.