Senior Director, Regulatory Affairs, CMC

Role Overview

• Lead and develop the U.S. Biologics Regulatory CMC team
• Provide strategic and operational leadership for global biologics Regulatory CMC strategies
• Partner closely with global cross-functional stakeholders on CMC regulatory strategies
• Establish and continuously improve Regulatory CMC standard operating procedures (SOPs)
• Ensure appropriate Regulatory CMC assessment throughout the product lifecycle
• Review and approve Regulatory CMC documentation within the RIM system
• Represent the company in external forums and regulatory or scientific conferences

Requirements

• BA/BS Degree in scientific disciplines, MS/PhD preferred
• 12+ years of relevant pharmaceutical or biopharmaceutical experience
• At least 10 years of direct Regulatory CMC experience
• Demonstrated track record of leading Health Authority interactions
• Proven experience leading and developing teams of 10+ or more professionals
• Advanced scientific training with hands-on expertise in at least one core pharmaceutical or biologics discipline
• In-depth knowledge of ICH guidelines and global Regulatory CMC requirements
• Extensive experience authoring, reviewing, and managing complex technical documentation

Benefits

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness