Senior Regulatory CMC Manager (Remote)

Regulatory Jobs; 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 is seeking an experienced Regulatory CMC specialist to contribute to cardiovascular therapeutic development. You will support US and global submissions, write and review CMC documents, and coordinate with Regulatory Affairs, CMC, and Quality to ensure compliance and milestones are met.

The role requires a BS/BA in a scientific field and 5+ years in regulatory CMC, with experience in document management systems like Veeva RIM.

Qualifications

• BS/BA in a scientific/health sciences discipline.
• 5+ years of experience in CMC Regulatory Affairs.
• Experience with Veeva RIM or similar document management system.
• Experience preparing submissions, regulatory documents, annual reports, amendments and supplements.
• Proven ability to strategize with team members in documenting submissions.

Responsibilities

• Contribute CMC regulatory input to product development and registrations for small molecule products.
• Prepare and compile CMC documents for US and global submissions (IMPD, INDs, CTAs, NDAs, MAAs, etc.).
• Provides critical review of CMC documentation and oversees data verification/QC.
• Collaborate with Regulatory Affairs, CMC, and Quality to ensure compliance across records and change controls.
• Prepare regulatory submissions using document management systems and archive regulatory documentation.
• Ensure CMC regulatory milestones are met to support submissions and company goals.
• Contribute to the development of overall regulatory strategies.
• May oversee external vendors and contractors providing regulatory support.

Skills

Regulatory CMC

Submission planning

Cross-functional collaboration

Regulatory strategy

Education

BS/BA in scientific/health sciences

Tools

Veeva RIM

Regulatory document management

Job description

Edgewise is seeking an experienced Regulatory CMC specialist to contribute to cardiovascular therapeutic development. You will support US and global submissions, write and review CMC documents, and coordinate with Regulatory Affairs, CMC, and Quality to ensure compliance and milestones are met.

The role requires a BS/BA in a scientific field and 5+ years in regulatory CMC, with experience in document management systems like Veeva RIM.