Biologics CMC Regulatory Manager

Regeneron Pharmaceuticals Inc.; Village of Tarrytown (NY); In loco; USD 108.000 - 176.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonuses

Equity awards

Pension / retirement benefits

401(k) company match

Health & wellness programs

Insurance benefits (medical, dental, (

Vision

Life and disability insurance

Paid time off

Family support benefits

Descrizione del lavoro

Regeneron Pharmaceuticals Inc. in Rensselaer, NY is seeking a Manager, CMC Regulatory Affairs - Biologics to lead regulatory strategy and compliance across development, submissions and post‑market activities.

You will collaborate with Global Regulatory Affairs and CMC teams to advance biologics products, ensure worldwide regulatory compliance, and support interactions with authorities. This on-site role combines scientific rigor with cross‑functional leadership.

Competenze

• Bachelor’s degree with 6+ years in pharmaceutical/biotech/Health Authority settings.
• Advanced degree with 3+ years in similar settings.
• 2-4 years of CMC Regulatory Affairs experience with worldwide regulations.
• Strong understanding of global CMC Regulatory Affairs requirements.
• Experience delivering CMC sections of marketing authorizations, CTA/INDs, and post-approval submissions.
• Experience supporting biologic products; FDA or other authorities experience is a plus.
• Ability to build cross-functional partnerships and deliver results in dynamic environments.

Mansioni

• 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 applicable regulations and guidelines.
• Support regulatory authority interactions, including meetings and information requests.
• Develop working instructions, SOPs, and reviewer’s guides for consistency.
• Identify regulatory process gaps and recommend efficiency improvements.

Conoscenze

Communication

Negotiation

Strategic thinking

Problem-solving

Formazione

Bachelor’s degree in pharmaceutical/biotech/health authority settings

Advanced degree (MS/PhD) in relevant field

Descrizione del lavoro

Regeneron Pharmaceuticals Inc. in Rensselaer, NY is seeking a Manager, CMC Regulatory Affairs - Biologics to lead regulatory strategy and compliance across development, submissions and post‑market activities.

You will collaborate with Global Regulatory Affairs and CMC teams to advance biologics products, ensure worldwide regulatory compliance, and support interactions with authorities. This on-site role combines scientific rigor with cross‑functional leadership.