Director, QA Regulatory Affairs

Director, QA Regulatory Affairs role at FUJIFILM Biotechnologies 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, 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 coordinates 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

Basic Requirements

Preferred Requirements

Working Conditions & Physical Requirements

To all agencies : Please, no phone calls or emails to any FUJIFILM employee about this requisition. All resumes submitted by search firms / employment agencies to any FUJIFILM employee via email, the internet, or in any form and / or method will be deemed the sole property of FUJIFILM, unless such search firms / employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

Seniority level

Employment type

Job function

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