Quality Assurance - Regulatory Affairs CMC Associate II

The Regulatory Affairs CMC Associate II is responsible for supporting the electronic publishing of regulatory submissions for national and regional regulatory agencies, and FUJIFILM Diosynth partner companies. The primary focus of this position is on moderate to complex regulatory submissions in both eCTD and non-eCTD format. Actual work assignments are based on the FUJIFILM Diosynth portfolio of work along with the incumbent's experience, knowledge, demonstrated technical skills, and competencies, or as part of an individual's development plan.

Regulatory Affairs 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.

External US

Essential Functions

• 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.
• 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.
• 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.
• 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.
• 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.
• Maintain proficiency on regulatory requirements; and FDA/Notified Body published reviews as applicable.
• 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.
• 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)
• May be necessary to work remotely at prescribed intervals.

Required Skills & Abilities

• Working knowledge of Regulatory Information Systems, planning and /or publishing tools.

• Working knowledge of and experience with various submission and application types, publishing templates and relevant regulatory agency and industry guidelines.
• Experience in electronic submission publishing processes and leading e-CTD tools
• Effective interpersonal, teamwork, networking, and communication skills.
• Proficiency in applying submission-readiness and publishing standards via Adobe Acrobat, MS Word and related applications.
• Demonstrated ability to build productive relationships across an organization and with FUJIFILM Diosynth partner companies is required
• Problem-solving capability, including trouble shooting and adaptability required.
• Understanding of the drug development process.
• Skill to apply knowledge of submission-readiness and publishing standards.
• Cell & Gene Therapy area and product knowledge, strong understanding of product development process.
• Fluency in English.
• Ability to work or lead in a matrix environment.
• Ability to execute assignments independently as assigned
• Must possess strong organization skills, strong written and verbal communication skills.
• Demonstrated ability to handle multiple competing priorities simultaneously.

Working Conditions & Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to

• Experience prolonged standing, some bending, stooping, and stretching.
• Ability to sit for long periods to work on a computer.
• Potential for exposure to chemicals, gases, fumes, odors, dusts, and other hazardous materials.
• Ability to wear personal protective equipment including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), cleanroom (ISO 8 to ISO 5) gowning material and appropriate shoes required in most areas associated with this position.
• Lifting to 25 pounds on occasion.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
• Must be willing to work flexible hours.
• Ability to work weekends and off-shift hours, as needed to support manufacturing activities.
• Must be willing to travel occasionally, as needed.
• Attendance is mandatory.

Minimum Qualifications

• Bachelor's degree or equivalent experience required and minimum of 2 years of related experience in a regulatory, quality, or similar position.

We are an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. 

If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3500.

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