Global Regulatory CMC Lead (Senior Manager)

Biopharma Careers; Wilmington (DE); On-site; USD 120,000 - 180,000; Full time

Job summary

Incyte Corporation seeks an experienced Regulatory CMC professional to manage submissions and strategy for development and marketed products, spanning small molecules and biologics from early development to post-approval. The role requires liaising with FDA and global authorities, ensuring compliant, high-quality submissions, and coordinating cross-functional teams.

The position emphasizes involvement in post-approval activities, changes management, and global program support, with domestic

Qualifications

• In-depth knowledge of pharmaceutical drug development and CMC guidelines.
• Experience in regulatory CMC or related development field.
• Experience with global clinical trial and marketing applications.
• Proficiency with eCTD submissions and regulatory documentation workflows.
• Willingness to travel up to 10% domestically.

Responsibilities

• Manage regulatory CMC strategy for small and large molecule programs.
• Coordinate with FDA and global health authorities as needed.
• Ensure CMC submissions meet current regulatory standards and high quality.
• Review CMC data packages and provide regulatory guidance to teams.
• Lead or participate in CMC strategy meetings with stakeholders.
• Oversee post-approval CMC activities and changes.

Skills

Regulatory CMC knowledge

eCTD submissions

FDA/global health authority liaison

Cross-functional collaboration

Education

Bachelor's degree in a relevant field

Advanced degree in Regulatory Affairs or related field

Tools

Electronic Document Management System (EDMS)

Job description

Incyte Corporation seeks an experienced Regulatory CMC professional to manage submissions and strategy for development and marketed products, spanning small molecules and biologics from early development to post-approval. The role requires liaising with FDA and global authorities, ensuring compliant, high-quality submissions, and coordinating cross-functional teams.

The position emphasizes involvement in post-approval activities, changes management, and global program support, with domestic