Global CMC Regulatory Strategy Senior Manager

Incyte; Wilmington (DE); On-site; USD 130,000 - 210,000; Full time

Job summary

Incyte is seeking a Regulatory CMC professional to manage submissions and strategy for its development and marketed products, spanning small molecules and biologics from early development through post-approval. The role requires coordinating with global authorities and cross-functional teams to ensure high-quality, compliant CMC documentation.

You will stay current with evolving FDA and international guidance, lead or participate in regulatory CMC meetings, and oversee post-approval activities

Qualifications

• In-depth knowledge of pharmaceutical drug development and CMC regulations governing development of pharmaceuticals/biotech products.
• Experience with regulatory CMC aspects of both large and small molecule drugs.
• Experience with global clinical trial and marketing applications, eCTD submissions, and electronic document management systems.

Responsibilities

• Participates in external meetings to apply the latest thinking to CMC strategies.
• Liaises with FDA and global health authorities; leads or participates in CMC-related meetings and prepares summaries for archives.
• Ensures CMC submissions meet regulatory standards and supports responses to inquiries from authorities.
• Leads regulatory CMC strategy and submission activities for small and large molecule programs.

Skills

Regulatory CMC knowledge

Pharmaceutical development

Cross-functional collaboration

Education

Bachelor's degree in a relevant field

Advanced degree in Regulatory Affairs or related field

Tools

eCTD systems

Job description

Incyte is seeking a Regulatory CMC professional to manage submissions and strategy for its development and marketed products, spanning small molecules and biologics from early development through post-approval. The role requires coordinating with global authorities and cross-functional teams to ensure high-quality, compliant CMC documentation.

You will stay current with evolving FDA and international guidance, lead or participate in regulatory CMC meetings, and oversee post-approval activities