Regulatory Affairs Manager

Job Summary

A company is looking for a Sr. Manager of Regulatory Affairs, Biologicals and Chemicals.

Key Responsibilities

• Interpret and communicate global regulations and guidelines impacting pharmaceutical ancillary materials
• Develop and implement drug support strategies for ancillary materials and off-label excipients
• Lead regulatory affairs talent and support customer due diligence processes

Required Qualifications

• Bachelor's Degree in Pharmaceutical Sciences, Chemistry, or related field; advanced degree preferred
• 7 years of experience in CMC regulatory affairs within the pharmaceutical industry
• 1+ year of experience leading a team of direct reports
• Strong background in pharmaceutical regulatory operations
• Experience in Excipient Manufacturing is a plus