Welcome page Returning Candidate? Log back in! Director, QA Regulatory Affairs Job Locations US-NC-Research Triangle Park Posted Date 1 day ago(8/27/2025 9:05 AM) Requisition ID 2025-35375 Category Regulatory/Compliance Company (Portal Searching) FUJIFILM Biotechnologies Position Overview

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.

 

Job Description

What You’ll Do

Leads, mentors, and sets the objectives for the Regulatory Affairs team across the North Carolina sitesPerforms regulatory surveillance and ensures effective implementation within the organizationServes as the SME and primary contact for regulatory inspections and audits, and strategic programs and harmonization across the organizationOversees and coordinates regulatory activities for multiple projects, ensuring compliance throughout the project lifecycleCollaborates with clients on regulatory responses and tracks commitments for timely closureDevelops and conducts training sessions to enhance regulatory knowledge to ensure adherence to best practicesParticipates in sustainability projects with a transformative and responsible approachEngages in industry groups, and publishes regulatory successes to drive industry transformationParticipates in site Quality Leadership Teams (QLTs) and coordinate regulatory assignmentsNavigates regulatory complexities and differences across microbial, mammalian, commercial, clinical, drug substance, and primary and secondary packaging at the North Carolina sitesEnsures alignment with Regulatory leaders globally for best practices, and consistent and transformative approachesPartners cross-functionally to identify areas for improvement, develop action plans, and collaborate to implement improvement initiativesManages regulatory activities such as Site Master File, 3.2.A.1, Drug Master Files, and customer filingAdministers 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 growthPartners with HR, Talent Acquisition, and various stakeholders to recruit talent and create retention strategies, as neededEvaluates 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 regulationsAbility to interpret regulations and apply to non-routine situationsDeep understanding of regulatory intelligence, US, EMEA, and ROW regulations and the accreditation of Foreign Manufacturers (FMA) in JapanWillingness to engage and align to KojoX and One FUJIFILM Biotechnologies initiativesAbility to adapt communications style to differing audiences, advise on difficult matters, and navigate crucial conversationsStrong orientation for quality, compliance, business ethics, and customer serviceHigh level of integrity, personal discipline and responsibilityExhibits strong collaboration, flexibility, and ability to manage multiple changing prioritiesStrong strategic thinking and project management skillsAbility to effectively present complex information to othersDemonstrated ability to hire and develop technical talent to lead a high performing team, projects, and programsWillingness to participate within industry groups and conferencesMust 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; orBachelor’s degree in life science or engineering field with 13+ years of regulatory experience in a pharmaceutical or manufacturing environment10+ 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

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