FUJIFILM Cellular Dynamics is a leading developer and supplier of human cells used in drug discovery, toxicity testing, stem cell banking, and cell therapy development. We partner with innovators from around the world to combine biologically relevant human cells with the newest technologies to drive advancements in medicine and healthier living. Our technology can be used to create induced pluripotent stem cells (iPSCs) from anyone and followed by the powerful capability to develop into virtually any cell type in the human body. Our proprietary manufacturing system result in inventoried iCell® products and donor-specific MyCell® Products in the quantity, quality, purity, and reproducibility required for drug and cell therapy development

We are in the market for qualified candidates for the newly created position of Regulatory Affairs Manager.  In this critical, and hands-on role you'll serve as the regulatory project lead and provide regulatory expertise and execution for regulatory activities, including planning, authoring, compiling, and submitting highest-quality regulatory submissions to the regulatory bodies within FCDI timelines and in accordance with regulatory guidelines and health authority requirements.  You will also align with internal and external subject matter experts to ensure effective execution of FCDI’s regulatory strategy.   We'll rely on you as key resource to ensure current knowledge and consistency with global regulatory rules and guidance, providing insight and guidance.

Essential Job Functions

1. Serve as regulatory project lead providing regulatory expertise for regulatory activities.
2. Execute strategic regulatory efforts for FCDI such as coordinating, authoring, and preparing regulatory submissions, and providing regulatory intelligence.
3. Review regulatory agency submission materials to ensure timeliness, accuracy, comprehensive, or compliance with regulatory agency requirements and standards. 
4. Prepare and/or review responses to agency information requests.
5. Develop and maintain internal procedures and processes to support regulatory activities.
6. Provide regulatory support with aligned stakeholders to ensure regulatory approvals.
7. Work cross-functionally to support therapeutics and FCDI regulatory compliance.
8. Train and provide guidance to applicable FCDI staff and stakeholders in regulatory policies and/or procedures.
9. Other job functions as assigned.

• Master’s degree life science discipline such as but not limited to cell biology, biochemistry, or microbiology, or Bachelor’s degree in comparable discipline plus two years of directly related experience
• Three years of relevant regulatory affairs experience in cell therapy, pharmaceutical, or biotech industries, with demonstrated achievements and progressive responsibilities, supporting development of FDA regulated products
• Regulatory Affairs Certification, preferred
• Demonstrated proficiency with regulatory interactions and submissions
• Highly skilled in project management and use of related tools
• Working knowledge of 21CFR Part 58
• In-depth knowledge of sections of the Code of Federal Regulations that apply to cell therapeutics, HCT/Ps, and gene therapeutics (21 CFR 210/211, 600/610, and 1271) in addition to related guidance documents
• Ability to identify, define, and solve problems; trouble-shoot, and influence across multiple viewpoints.
• Demonstrated and effective communication skills
• Demonstrated proficiency with change and conflict management, with ability to influence and align divergent viewpoints
• Functional proficiency with MS Office suite
• Overnight – to include international travel – 10%
• Able to work at computer for extended periods of time

FUJIFILM Cellular Dynamics, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status or status as an individual with a disability. All qualified applicants will not be discriminated against on the basis of a disability.