Summary:The Principle I, GRA-CMC is responsible for providing site-based global regulatory CMC leadership and support for the Sanford manufacturing facility. The role serves as the primary interface between the Sanford site and the global GRA-CMC organization, ensuring that site regulatory activities are aligned with global regulatory strategy, applicable requirements, and business priorities.
The role is responsible for regulatory activities associated with the FDA PreCheck pilot program and the Sanford Type V DMF, as well as providing GRA-CMC representation for site technology transfer activities. The position also provides regulatory CMC support to address the evolving regulatory requirements of the Sanford site and development pipeline.
Essential Functions:• Serve as the primary GRA-CMC interface for the Sanford site, providing regulatory CMC leadership, strategic guidance, and oversight to ensure site activities are aligned with global regulatory strategies, applicable requirements, and company standards.
• Direct GRA-CMC activities associated with the FDA PreCheck program, including preparation for FDA interactions, regulatory communications, responses to agency requests, and associated follow-up activities.
• Own the preparation, submission, and lifecycle management of the Sanford Type V DMF, ensuring that content remains accurate, current, and aligned with applicable regulatory requirements and product development and manufacturing activities.
• Represent GRA-CMC within Sanford technology transfer activities, ensuring regulatory requirements, filing considerations, and regulatory commitments are identified early and appropriately incorporated into technical strategies and execution plans.
• Assess regulatory CMC implications of Sanford site changes and manufacturing activities, including facility readiness, process and equipment changes, technical initiatives, and other site-related activities with potential regulatory impact.
• Establish and maintain effective partnerships with Sanford Quality, Manufacturing, MSAT, Supply Chain, and other technical functions, as well as global GRA-CMC and development teams, to ensure timely identification, assessment, and resolution of regulatory CMC matters.
• Proactively identify and evaluate regulatory CMC risks, developing appropriate mitigation strategies to support compliant and timely execution of site and development activities.
• Contribute to regulatory submissions and health authority interactions for products manufactured or planned to be manufactured at Sanford, including assessment of CMC information, responses to regulatory questions, and other activities as required.
• Shape regulatory CMC input into site and product lifecycle planning, including assessment of regulatory implications associated with manufacturing strategy, process changes, product introductions, and other business or development initiatives.
• Support Sanford regulatory inspection readiness and execution, as applicable, including preparation for regulatory inspections, participation in inspection activities, and development of responses and remediation plans related to CMC matters.
• Monitor and coordinate regulatory commitments and CMC actions associated with Sanford activities, working with relevant stakeholders to support timely and compliant completion.
• Contribute to broader GRA-CMC post-approval maintenance activities and portfolio priorities, adapting support as business needs, regulatory requirements, and development priorities evolve
Requirements:Education
Bachelor's degree in a relevant scientific discipline, such as Pharmacy, Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or closely related field. Advanced degree (M.S., Pharm.D., Ph.D., or equivalent) preferred, particularly in a pharmaceutical, scientific, or regulatory discipline.
Experience
• 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; exposure to regulatory activities in other major markets (e.g., EU, UK, and ROW) preferred.
• Demonstrated success managing complex regulatory CMC activities and projects across multiple functions, including site, technical, quality, manufacturing, and global regulatory organizations.
• Prior involvement in FDA interactions and health authority engagements, including preparation of regulatory materials, responses to agency questions, and follow-up activities.
• Background in manufacturing site regulatory activities, including technology transfers, manufacturing changes, facility readiness, and evaluation of regulatory impact.
• Hands-on involvement in the preparation, submission, and/or maintenance of Type V DMFs or other CMC regulatory dossiers strongly preferred.
• Demonstrated application of regulatory strategy and sound judgment to identify risks, evaluate options, and develop practical approaches to complex CMC issues.
• Track record of working effectively within a matrixed organization and influencing outcomes across site-based and global functions without direct authority.
Technical Skills
• In-depth knowledge of U.S. FDA biopharmaceutical CMC regulatory requirements, including expectations for development, manufacturing, post-approval changes, technology transfer, and lifecycle management.
• Strong understanding of the FDA PreCheck Pilot Program and its regulatory framework, including the role of early FDA engagement, facility information, Type V DMFs, pre-operational reviews, facility readiness, and subsequent application and inspection activities.
• Proficiency in CMC regulatory submissions and documentation, including BLA-related CMC content, post-approval supplements, Type V DMFs, regulatory responses, and supporting technical documentation.
• Regulatory strategy and analytical capabilities to evaluate CMC regulatory risks, interpret complex technical information, and develop practical, risk-based recommendations.
• Advanced regulatory writing and presentation capabilities, with the ability to communicate complex scientific and regulatory concepts clearly to technical, site, senior leadership, and health authority audiences.
• Cross-functional communication and stakeholder management skills, with the ability to build alignment, influence decision-making, and effectively communicate regulatory strategy and risk across site and global functions.
• Proficiency with Microsoft Office Suite, including Word, Excel, PowerPoint, and Outlook; familiarity with electronic regulatory submission and document management systems preferred.
• Familiarity with electronic regulatory submission and document management systems and other tools used to prepare, track, and maintain regulatory documentation preferred.prepare, track, and maintain regulatory documentation preferred.
Non-Technical SkillsDemonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quickly. Strong work ethic is required. Detail oriented and excellent follow through. Has the ability to flex and deal with ambiguity in a dynamic, fast-paced, high growth environment. Has a passion for personal learning and development to be able to grow with the company. Cultural sensitivity and ability to develop consensus within a multinational organization.
Physical Demands:Initially working on a construction site and ultimately in a biotech manufacturing site in Sanford, NC; normal office environment with prolonged sitting and extensive computer work.
Work is 100% on-site. This is not a hybrid or remote role.
Working Conditions:Requires up to 10% domestic and international travel
The anticipated salary for this position will be
$140,000 to $175,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
- 401K with company matching
- Annual Bonus Program (Sales Bonus for Sales Jobs)
- 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 (subject to job level and performance)
- Life & Disability Insurance
- Concierge Service
- Pet Insurance
- Tuition Assistance
- Employee Referral Awards
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
#LI-TT1 #Sanford #OnSite
