Sr Specialist, Regulatory Affairs at FUJIFILM Holdings America Corporation
Holly Springs, NC 27540
About the Job
Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO
The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.
Join us
We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.
The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.
External US
About This Role
The Sr. Specialist, Regulatory Affairs, provides critical insights on FDA and EMA expectations while planning and executing expansion meetings with regulatory authorities. This role serves as a liaison between commercial, operations, and expansion project teams, guiding efforts to maintain manufacturing flexibility with minimal regulatory impact. Sr. Specialist establishes and maintains the site master file, licenses, and eCTD documentation, as well as participates in a cross-site regulatory network and sustainability initiatives.
Additionally, this role acts as the primary contact for the commercial team regarding new customers and engages with industry groups to influence future regulatory interpretations.
What You’ll Do
Basic Requirements
of applicable industry experience OR
experience OR
experience
guidelines, and submission processes.
strategies.
Master Files (SMF), Drug Master Files (DMF), and electronic Common
Technical Documents (eCTD)
Preferred Requirements
Working Conditions & Physical Requirements
- Ability to discern audible cues
- Ability to stand for prolonged periods of time up to 30 minutes
- Ability to sit for prolonged periods of time up to 120 minutes
FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email
.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM 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.
