Biologics CMC Regulatory Affairs Lead

Regeneron Pharmaceuticals Inc.; Warren Township (NJ); Presencial; USD 108 000 - 176 000; Tempo integral

Resumo da oferta

Regeneron Pharmaceuticals Inc. seeks a Manager, CMC Regulatory Affairs - Biologics to lead regulatory strategy across development, submissions, and post‑market programs for its biologics portfolio.

This on‑site role collaborates with Global Regulatory Affairs and CMC teams to ensure compliance and timely filings. The position requires 6+ years in pharma/biotech or 3+ years with an advanced degree, with experience delivering CMC sections of MAAs, CTAs/INDs, and post‑approval submissions.

Qualificações

• Bachelor’s degree with 6+ years, or advanced degree with 3+ years, in pharmaceutical, biotechnology, or Health Authority 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 preferred.
• Experience engaging with FDA or other regulatory authorities preferred.
• Strong communication, negotiation, strategic thinking, and problem-solving skills.
• Ability to build cross-functional partnerships, manage competing priorities, and deliver results in dynamic environments.
• Ability to support training activities and proactively address technical or regulatory knowledge gaps.

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 applicable regulations and guidelines.
• Support regulatory authority interactions, including meetings and information request responses.
• Develop Working Instructions, SOPs, and Reviewer’s Guides to improve consistency.
• Identify regulatory process gaps and recommend efficiency improvements.
• You translate ambiguity into actionable steps and build alignment across teams.

Conhecimentos

CMC Regulatory Affairs

Biologics experience

Regulatory submissions

Stakeholder communication

Cross-functional collaboration

Formação académica

Bachelor’s degree in pharma/biotech

Advanced degree

Descrição da oferta de emprego

Regeneron Pharmaceuticals Inc. seeks a Manager, CMC Regulatory Affairs - Biologics to lead regulatory strategy across development, submissions, and post‑market programs for its biologics portfolio.

This on‑site role collaborates with Global Regulatory Affairs and CMC teams to ensure compliance and timely filings. The position requires 6+ years in pharma/biotech or 3+ years with an advanced degree, with experience delivering CMC sections of MAAs, CTAs/INDs, and post‑approval submissions.