Remote CMC Regulatory Lead

Edgewise Therapeutics, Inc.; United States; Remote; USD 150,000 - 210,000; Full time

Job summary

Edgewise Therapeutics, Inc. is seeking a Regulatory CMC professional to contribute to cardiovascular therapeutic development teams.

The role encompasses regulatory CMC input for product development and submissions for US and global programs, with collaboration across Regulatory Affairs, CMC, and Quality to ensure compliance and successful milestones. Requirements include 5+ years in CMC Regulatory Affairs, experience with submissions (INDs, NDAs), and familiarity with Veeva RIM; remote work

Qualifications

• 5+ years of experience in CMC Regulatory Affairs.
• Experience preparing submissions and regulatory documents.
• Knowledge of US and global regulatory submissions (IND/NDAs) and lifecycle management.
• Experience with regulatory document management systems is preferred.

Responsibilities

• Contributes regulatory CMC input to product development and registration for small molecule products.
• Writes, edits, and compiles CMC documents for US and global submissions (INDs, NDAs, MAAs, etc.).
• Reviews CMC documentation and ensures data QA and traceability.
• Collaborates with Regulatory Affairs, CMC, and Quality to ensure compliance and change controls.
• Prepares regulatory submissions using document management systems and archives.
• Supports development of overall regulatory strategies and milestones.

Skills

CMC Regulatory Affairs

Regulatory Strategy

Cross-functional Collaboration

Regulatory Submissions

Veeva RIM experience

Tools

Veeva RIM

Job description

Edgewise Therapeutics, Inc. is seeking a Regulatory CMC professional to contribute to cardiovascular therapeutic development teams.

The role encompasses regulatory CMC input for product development and submissions for US and global programs, with collaboration across Regulatory Affairs, CMC, and Quality to ensure compliance and successful milestones. Requirements include 5+ years in CMC Regulatory Affairs, experience with submissions (INDs, NDAs), and familiarity with Veeva RIM; remote work