Principal I, Global Regulatory Affairs-CMC

The role

The Principal I, GRA-CMC provides site-based global regulatory CMC leadership and support for the Sanford manufacturing facility. This role serves as the primary interface between the Sanford site and the global GRA-CMC organization to align site activities with global strategy and requirements.

What you will do

• Serve as the primary GRA-CMC interface for the Sanford site
• Direct GRA-CMC activities associated with the FDA PreCheck program
• Own the preparation, submission, and lifecycle management of the Sanford Type V DMF
• Represent GRA-CMC within Sanford technology transfer activities
• Assess regulatory CMC implications of Sanford site changes and manufacturing activities
• Establish and maintain partnerships with Sanford technical functions and global teams
• Identify and evaluate regulatory CMC risks and develop mitigation strategies
• Contribute to regulatory submissions and health authority interactions
• Shape regulatory CMC input into site and product lifecycle planning
• Support Sanford regulatory inspection readiness and execution

Required qualifications

• Bachelor’s degree in a relevant scientific discipline, such as Pharmacy, Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or closely related field
• Minimum eight (8) years of progressive regulatory affairs experience within the biotechnology, pharmaceutical, or life sciences industry, with substantial focus on CMC regulatory affairs
• Proven track record supporting U.S. BLA post-approval activities and lifecycle management
• Demonstrated success managing complex regulatory CMC activities and projects across multiple functions
• Prior involvement in FDA interactions and health authority engagements
• Background in manufacturing site regulatory activities, including technology transfers, manufacturing changes, and facility readiness
• Demonstrated application of regulatory strategy and sound judgment
• Track record of working effectively within a matrixed organization
• In-depth knowledge of U.S. FDA biopharmaceutical CMC regulatory requirements
• Strong understanding of the FDA PreCheck Pilot Program and its regulatory framework
• Proficiency in CMC regulatory submissions and documentation
• Advanced regulatory writing and presentation capabilities

Nice to have

• Advanced degree (M.S., Pharm.D., Ph.D., or equivalent)
• Exposure to regulatory activities in other major markets (e.g., EU, UK, and ROW)
• Hands-on involvement in the preparation, submission, and/or maintenance of Type V DMFs or other CMC regulatory dossiers
• Familiarity with electronic regulatory submission and document management systems

Benefits

• 401K with company matching
• Annual Bonus Program
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Long-Term Incentive Program
• Life & Disability Insurance
• Concierge Service
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

About the company

Kyowa Kirin is a global specialty pharmaceutical company backed by more than 70 years of breakthrough life science innovation. The company works across the continuum from drug discovery to commercialization.