Principal I, Global Regulatory Affairs-CMC

Kyowa Kirin•Sanford, NJ

4d•Onsite

About The Position

Kyowa Kirin is a global specialty pharmaceutical company dedicated to discovering and advancing treatments for diseases with unmet needs. This role, Principal I, GRA-CMC, is responsible for providing site-based global regulatory CMC leadership and support for the Sanford manufacturing facility. The position acts as the main liaison between the Sanford site and the global GRA-CMC organization, ensuring that site regulatory activities align with global regulatory strategy, applicable requirements, and business priorities. Key responsibilities include managing regulatory activities for the FDA PreCheck pilot program and the Sanford Type V DMF, representing GRA-CMC in site technology transfer activities, and providing regulatory CMC support for evolving regulatory requirements impacting the Sanford site and its development pipeline.

Requirements

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, 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.
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.
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.
Demonstrated 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.

Nice To Haves

Advanced degree (M.S., Pharm.D., Ph.D., or equivalent) preferred, particularly in a pharmaceutical, scientific, or regulatory discipline.
Exposure to regulatory activities in other major markets (e.g., EU, UK, and ROW) preferred.
Hands-on involvement in the preparation, submission, and/or maintenance of Type V DMFs or other CMC regulatory dossiers strongly preferred.
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.

Responsibilities

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.

Benefits

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