Director, Global Regulatory Affairs CMC

We are seeking a Director, Global Regulatory Affairs CMC to lead the execution of regulatory CMC strategies for assigned products and contribute to the team's delivery of critical functions. The ideal candidate will have a strong understanding of GRA CMC regulations and guidelines, excellent analytical and communication skills, and experience in leading major submissions during LCM, development, and commercialization.

Requirements

• BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) required
• 10+ years of overall biopharmaceutical/device industry experience
• 8+ years pharmaceutical Regulatory CMC and / or devices experience
• Experience in leading major submissions during LCM, development, and commercialization
• Understanding of scientific principles and regulatory CMC requirements
• Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams
• Excellent written and oral communication skills
• Ability to analyze issues with attention to detail and assess alternative approaches
• Emerging leadership, problem-solving ability, flexibility, and values teamwork

Benefits

• Medical, dental, vision insurance
• 401(k) plan and company match
• Short-term and long-term disability coverage
• Basic life insurance
• Tuition reimbursement program
• Paid volunteer time off
• Company holidays
• Well-being benefits