Sr Manager/Assoc Director, CMC Regulatory Affairs

📋 Description

• Deliver CMC regulatory support through QC review of submission components.
• Prepare/review CMC regulatory documents and submissions (ND/CTA).
• Assess proposed CMC changes and support global filing strategies.
• Collaborate cross-functionally on eTMF processes and compliance alignment.
• Represent regulatory on study/program teams during development.
• Support or lead global regulatory submissions; respond to health authority requests.

🎯 Requirements

• Undergraduate degree required; advanced degree preferred.
• 5+ years in pharma/biotech regulatory affairs, incl. oncology.
• Ability to translate regulatory requirements into practical plans.
• Experience creating systems and processes for efficient submissions.
• Strong organizational skills with attention to detail.
• Strong interpersonal/communication skills; collaborative team player.

🎁 Benefits

• Paid Time Off, Holidays, and Sick Leave
• Medical, Dental and Vision Plans
• Short- and Long-Term Disability
• Flexible Spending Accounts (FSA/HSA/Commute)
• 401(k) Plan with Erasca contribution
• Employee Stock Purchase Program