QA Supervisor - Regulatory Affairs

FUJIFILM Biotechnologies; College Station (TX); Sur place; USD 80 000 - 115 000; Plein temps

Résumé du poste

FUJIFILM Diosynth Biotechnologies Texas LLC, Bryan, TX, seeks a QA Supervisor - Regulatory Affairs to lead regulatory publishing for national and regional agencies. You will coordinate data from internal teams, prepare documentation for eCTD and non-eCTD submissions, and ensure compliance with GMP/GXP, design controls, and regulatory obligations.

The role requires a Master’s or Bachelor’s with extensive regulatory experience, and involves collaboration with cross-functional teams to secure

Description du poste

Position Overview

Job Title: QA Supervisor - Regulatory Affairs

Worksite: Bryan, TX

QA Supervisor - Regulatory Affairs for FUJIFILM Diosynth Biotechnologies Texas LLC, Bryan, TX. Responsible for supporting the electronic publishing of regulatory submissions for national and regional regulatory agencies, and FUJIFILM Diosynth partner companies with the primary focus on moderate to complex regulatory submissions in both eCTD and non-eCTD format. Supports all CMC regulatory affairs activities for FUJIFILM Diosynth partner companies' products, summarize regulatory intelligence, provides CMC regulatory input for regulatory submissions, and manages the compilation and SME review of CMC sections of all submissions for completeness and quality.(25%). Specific job duties include the following: Obtain data/documents from multiple internal teams for exchange and/or communication with FUJIFILM Diosynth partner companies. Upload information to the Regulatory documentation management location for future use.(25%) May be required to compile and report key information to pertinent stakeholders within the Quality team to ensure proper visibility and communication. Support a vibrant regulatory culture, working among functional groups as a teammate and collaborator to develop successful regulatory strategies.(10%). Produce and manage the generation of documentation to be submitted to worldwide governmental regulatory agencies to secure approvals for marketing products manufactured and/or distributed by FUJIFILM Diosynth partners. (15%) Support development teams working towards modifying existing processes or creating new processes; ensure compliance with existing design controls, risk management, and domestic and international regulations.(5%) Ensure timely approvals, communicate, and support negotiations with the FDA and other regulatory bodies as needed to identify pre-submission requirements and strategy and to resolve post-submission queries and issues.(5%) Maintain proficiency on regulatory requirements; and FDA/Notified Body published reviews as applicable.(5%) Provide continuing regulatory education and disseminate regulatory information to the product development, marketing, and clinical groups. Ensure that regulatory intelligence communications are disseminated in a timely manner to the appropriate business functions. (5%) Be responsible for ensuring personal and Company compliance with all Federal, State local, and Company regulations, policies, and procedures. Support the review and negotiation of Master Service Agreements (MSA) and Quality Agreements (QAg).(5%)

Company Overview

The work we do at FUJIFILM Biotechnologies Texas has never been more important-and we are looking for passionate, mission-driven people like you who want to make a real difference in people's lives.

From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions.

If you're ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we're proud to cultivate a culture that will fuel your passion, energy, and drive-what we call Genki.

Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it's a dynamic location that blends convenience with innovation.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles". Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

Requirements

Master's degree in Material Science, Biochemistry, Quality Assurance or related biology/science field and three (3) years experience as a senior regulatory affairs analyst, senior quality control/assurance analyst or related occupation in regulatory affairs; OR Bachelor's degree and five (5) years experience as a senior regulatory affairs analyst, senior quality control/assurance analyst or related occupation in regulatory affairs.

• Regulatory experience in a pharmaceutical or regulated industry;
• GMP/GXP or a comparable heavily regulated environment;
• Regulatory Information Systems, planning and/or publishing tools.

Must possess one year of experience in the review and preparation of regulatory documentation for regulatory intelligence/compliance, supporting e-CTD publishing, maintenance of the company regulations and CDMO-related regulatory obligations

Must possess the following knowledge/skills: Cell & Gene Therapy area and biologics product knowledge; Product science and product development

Salary: $80,400 - $115,000 / year

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail] or [phone]).