Remote CMC Regulatory Manager - Small Molecule Drugs

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

Benefits offered by this job

Health benefits

Discretionary bonus plan

Stock option grants

Stock purchase plan

401(k) with match

Paid time off

Job summary

Edgewise Therapeutics, Inc. seeks a senior CMC Regulatory Affairs professional to contribute regulatory CMC expertise to cardiovascular programs.

The role supports US and global submissions, engages with Regulatory, CMC, and Quality teams, and guides submission strategies to meet milestones. Ideal candidates will have 5+ years in CMC Regulatory Affairs, experience with regulatory documents, and a track record of coordinating cross-functional teams in a remote work environment.

Qualifications

• BS/BA degree in a scientific/health sciences discipline.
• 5+ years of experience in CMC Regulatory Affairs.
• Experience with Veeva RIM or similar document management system.
• Experience in preparing regulatory submissions and regulatory documents.
• Knowledge of global regulatory trends and lifecycle management.

Responsibilities

• Contribute regulatory CMC input to product development and registration efforts for small molecules.
• Prepare and compile CMC documents for US and global submissions (IMPD, INDs, CTAs, NDAs, MAAs, briefing documents).
• Review CMC documentation for regulatory submissions and QC.
• Collaborate with Regulatory Affairs, CMC, and Quality to ensure compliance and change controls.
• Develop regulatory submission strategies and manage timelines; coordinate with vendors as needed.

Skills

CMC Regulatory Affairs

Regulatory submissions

Cross-functional work

Remote work experience

Regulatory strategy

Education

BS/BA in science/health sciences

Tools

Veeva RIM

Job description

Edgewise Therapeutics, Inc. seeks a senior CMC Regulatory Affairs professional to contribute regulatory CMC expertise to cardiovascular programs.

The role supports US and global submissions, engages with Regulatory, CMC, and Quality teams, and guides submission strategies to meet milestones. Ideal candidates will have 5+ years in CMC Regulatory Affairs, experience with regulatory documents, and a track record of coordinating cross-functional teams in a remote work environment.