Job Summary

• The Senior Scientist, Product Lead CMC Regulatory Affairs is a leading expert individual contributor responsible for major portions of complex regulatory submissions and conveying information to clinical development, commercial, and medical affairs teams.
• Responsibilities include contributing to global CMC regulatory strategies, participating as the Regulatory CMC Lead on CMC Teams, supporting global regulatory filings, and preparing regulatory dossiers for submission to Health Authorities.
• The role requires a BS in biological, pharmaceutical, chemical or engineering sciences with a minimum of 6+ years of experience, with an MS, Ph.D., or Pharm. D. degree preferred, and demonstrated ability to communicate regulatory requirements.

Matching Summary

Salary

Base: $109,000.00 - $174,800.00; Bonus/Equity: Not specified; Benefits: Vacation –120 hours per calendar year, Sick time - 40 hours per calendar year, Holiday pay –13 days per calendar year, Work, Personal and Family Time - up to 40 hours per calendar year, Parental Leave – 480 hours, Bereavement Leave – 240 hours, Caregiver Leave – 80 hours, Volunteer Leave – 32 hours, Military Spouse Time-Off – 80 hours

Skills & Requirements

Key Requirements

• BS degree with 6+ years experience
• MS, Ph.D., or Pharm. D. preferred
• demonstrated ability to communicate regulatory requirements
• working knowledge of global HA laws

Work Rights