The Director, QA Regulatory Affairs is a pivotal role providing regulatory expertise and leadership to the FUJIFILM Biotechnologies North Carolina sites, and globally, as needed. This role serves as the subject matter expert (SME) for regulatory practices and procedures, offering strategic direction throughout the organization. Additionally, the Director leads a team of regulatory specialists through fostering a culture of growth and development in alignment to organizational goals while collaborating cross-functionally to drive continuous improvement and optimize Regulatory approaches.

What You’ll Do

• Leads, mentors, and sets the objectives for the Regulatory Affairs team across the North Carolina sites
• Performs regulatory surveillance and ensures effective implementation within the organization
• Serves as the SME and primary contact for regulatory inspections and audits, and strategic programs and harmonization across the organization
• Oversees and coordinates regulatory activities for multiple projects, ensuring compliance throughout the project lifecycle
• Collaborates with clients on regulatory responses and tracks commitments for timely closure
• Develops and conducts training sessions to enhance regulatory knowledge to ensure adherence to best practices
• Participates in sustainability projects with a transformative and responsible approach
• Engages in industry groups, and publishes regulatory successes to drive industry transformation
• Participates in site Quality Leadership Teams (QLTs) and coordinate regulatory assignments
• Navigates regulatory complexities and differences across microbial, mammalian, commercial, clinical, drug substance, and primary and secondary packaging at the North Carolina sites
• Ensures alignment with Regulatory leaders globally for best practices, and consistent and transformative approaches
• Partners cross-functionally to identify areas for improvement, develop action plans, and collaborate to implement improvement initiatives
• Manages regulatory activities such as Site Master File, 3.2.A.1, Drug Master Files, and customer filing
• Administers company policies and completes required tasks (e.g., time off approvals, expense reports etc.)
• Encourages a culture that prioritizes continuous learning and development, including coaching and real-time feedback to ensure the team is positioned for growth
• Partners with HR, Talent Acquisition, and various stakeholders to recruit talent and create retention strategies, as needed
• Evaluates team performance, addresses gaps and implements measures to improve productivity and engagement, and develops high-potential employees
  
• Performs other duties, as assigned

Knowledge and Skills

• Knowledge of Good Manufacturing Practices (GMP) and other related regulations
• Ability to interpret regulations and apply to non-routine situations
• Deep understanding of regulatory intelligence, US, EMEA, and ROW regulations and the accreditation of Foreign Manufacturers (FMA) in Japan
• Willingness to engage and align to KojoX and One FUJIFILM Biotechnologies initiatives
• Ability to adapt communications style to differing audiences, advise on difficult matters, and navigate crucial conversations
• Strong orientation for quality, compliance, business ethics, and customer service
• High level of integrity, personal discipline and responsibility
• Exhibits strong collaboration, flexibility, and ability to manage multiple changing priorities
• Strong strategic thinking and project management skills
• Ability to effectively present complex information to others
• Demonstrated ability to hire and develop technical talent to lead a high performing team, projects, and programs
• Willingness to participate within industry groups and conferences
• Must be flexible to support 24/7 manufacturing facilities and collaborate with global colleagues

Basic Requirement

• Master’s degree in life science or engineering field with 11+ years of regulatory experience in a pharmaceutical or manufacturing environment; or
• Bachelor’s degree in life science or engineering field with 13+ years of regulatory experience in a pharmaceutical or manufacturing environment
• 10+ years of people management, leadership & team management experience

Preferred Requirements 

• Regulatory and GMP experience in the pharmaceutical industry

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

Ability to stand for prolonged periods of time. No X Yes 30 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)
Ability to sit for prolonged periods of time. No X Yes 30 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)
Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers. No X Yes
Ability to operate machinery and/or power tools. X No Yes
Ability to conduct work that includes moving objects up to X pounds. X No Yes If yes, 10 lbs. 33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. X No Yes