Senior Manager, CMC Regulatory Strategy

Incyte Corporation; Wilmington (DE); On-site; USD 120,000 - 190,000; Full time

Job summary

Incyte Corporation seeks a Regulatory CMC professional to lead submissions and strategy for both small molecules and biologics from development through post‑approval. You will coordinate with FDA and global health authorities, ensuring high-quality, compliant CMC data packages for clinical trials and marketing applications.

The role requires deep knowledge of pharmaceutical development, global regulatory requirements, and experience with eCTD submissions. Travel up to 10% is possible as needed.

Qualifications

• In-depth knowledge of pharmaceutical drug development and CMC regulations/guidelines.
• Experience with regulatory CMC aspects of large and small molecule drugs.
• Experience with global clinical trials and marketing applications, eCTD submissions, and document management systems.
• A degree in a relevant field is required; advanced degrees desirable but not mandatory with equivalent experience.
• Willingness to travel domestically up to 10%.

Responsibilities

• Participates in professional development meetings to apply latest CMC strategies.
• Maintains knowledge of US and international guidance and regulations affecting CMC drug development.
• Liaises with FDA and global health authorities; leads or participates in CMC health authority meetings.
• Ensures CMC submissions meet regulatory standards and high-quality data packages.
• Oversees post-approval global product activities and variations; provides timely responses to regulatory questions.
• Leads or participates in meetings to communicate CMC guidance and strategies.

Skills

Regulatory CMC knowledge

FDA liaison

Regulatory strategy

Cross-functional communication

Education

Bachelor's degree in a relevant field

Advanced degree in Regulatory Affairs or related field

Tools

eCTD submissions

Electronic document management systems

Job description

Incyte Corporation seeks a Regulatory CMC professional to lead submissions and strategy for both small molecules and biologics from development through post‑approval. You will coordinate with FDA and global health authorities, ensuring high-quality, compliant CMC data packages for clinical trials and marketing applications.

The role requires deep knowledge of pharmaceutical development, global regulatory requirements, and experience with eCTD submissions. Travel up to 10% is possible as needed.