CMC Regulatory Scientist: Global Submissions & Strategy

Regulatory Jobs; United States; On-site; USD 62,000 - 92,000; Full time

Job summary

Regeneron 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 marketing submissions and coordinate responses to agency inquiries to meet timelines.

The role emphasizes collaboration with cross-functional teams, contract manufacturers and regulatory partners, applying FDA/ICH CGMP guidelines and contributing to CMC regulatory strategy. On-site work is required in many cases.

Qualifications

• BA/BS degree or equivalent required.
• 2 years of relevant experience for Specialist level.
• 5 years of relevant experience for Senior Specialist level.
• Degree in a scientific field preferred.
• Advanced degree preferred.

Responsibilities

• Prepare global CMC documents for regulatory submissions.
• Coordinate authoring, review and responses to CMC inquiries.
• Collaborate with cross-functional teams and external partners.
• Apply regulatory guidance and CGMP knowledge.
• Review CMC documents for completeness and regulatory compliance.
• May oversee projects and staff assignments.

Skills

Regulatory knowledge

CMC submissions

Communication

Project management

Education

BA/BS degree

Scientific degree preferred

Job description

Regeneron 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 marketing submissions and coordinate responses to agency inquiries to meet timelines.

The role emphasizes collaboration with cross-functional teams, contract manufacturers and regulatory partners, applying FDA/ICH CGMP guidelines and contributing to CMC regulatory strategy. On-site work is required in many cases.