Sr Specialist, Regulatory Affairs

Overview

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 

 

• Serves as the primary regulatory contact and liaison between commercial, operations, and expansion project teams to establish and maintain FDBN relationships.• Leads and manages regulatory documentation processes, including the Site Master File (SMF), 3.2.A.1 documentation, Drug Master File (DMF), dossier review and writing, and eCTD documentation.• Supports and optimizes the regulatory aspects of tech transfer and new product introductions, while enhancing the regulatory intelligence process both locally and across the FDB network.• Reviews and provides regulatory input on customer Statements of Work (SOW) and Quality Agreements (QUAG).• Actively participates in industry groups (such as BioPharma) to ensure FDB representation and appropriate involvement in working groups.• Provides expert insights on FDA and EMA expectations to guide organizational decision-making and manages manufacturing flexibility initiatives with minimal regulatory impact.• Manages cross-functional collaborative projects and leads team assignments that align with strategic, operational, and technical leadership goals.• Plans and executes expansion meetings with regulatory authorities.• Primary point of contact for the commercial team regarding new customers.• Engages proactively with industry groups to influence future regulatory interpretations and standards.• Participates in cross-site regulatory network and sustainability projects.• Performs other duties, as assigned.

 

Basic Requirements

 

• Bachelor’s in Life Sciences or Engineering or equivalent with 8+ years of applicable industry experience OR• Masters in Life Sciences or Engineering and 6+ years of applicable experience OR• PhD in Life Sciences or Engineering and 4+ years of applicable experience• Prior experience and knowledge of FDA and EMA regulations, guidelines, and submission processes.• Prior experience in developing and implementing regulatory strategies.• Experience in managing regulatory documentation, including Site Master Files (SMF), Drug Master Files (DMF), and electronic Common Technical Documents (eCTD)

 

Preferred Requirements

 

• Previous experience with Quality System software and general IT savviness.• Experience with complex projects to keep work pace and meet deadlines with good organization and planning skills.• Experience in conducting regulatory risk assessments and developing mitigation strategies

• Training and/or familiarity with Quality Risk Management principles

 

Working Conditions & Physical Requir