Quality Assurance - Regulatory Affairs CMC Supervisor
Company: FUJIFILM Diosynth Biotechnologies
Location: College Station
Posted on: May 14, 2022
Summary: The Regulatory Affairs CMC Supervisor 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
- Instill and drive a vibrant regulatory culture, working among
functional groups as a teammate and collaborator to develop
successful regulatory strategies.
- Establish and support policies and standards for new product
introductions while ensuring compliance with global regulations and
- Interpret the intent of regulations and policies and provide
such information to project teams and management.
- 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
- 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
- Ensure that regulatory intelligence communications are
disseminated in a timely manner to the appropriate business
- Be responsible for ensuring personal and Company compliance
with all Federal, State local, and Company regulations, policies,
- Support the review and negotiation of Master Service Agreements
(MSA) and Quality Agreements (QAg)
- Provide day-to-day guidance, mentorship and supervision to
entry-level staff with periodic performance reviews.
- 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
- 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
- Problem-solving capability, including trouble shooting and
- Understanding of the drug development process.
- Skill to apply knowledge of submission-readiness and publishing
- 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
- Use hand-eye coordination and manual dexterity sufficient to
operate a keyboard, photocopier, telephone, calculator, and other
office equipment is required
- Attendance is mandatory Minimum Qualifications:
- University/Bachelor's degree or equivalent experience required
and minimum of 3 years' related experience in a regulatory,
quality, or similar position and 1 year in a related leadership
- CQA 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 or call .#LI-SB2
Keywords: FUJIFILM Diosynth Biotechnologies, College Station , Quality Assurance - Regulatory Affairs CMC Supervisor, Other , College Station, Texas
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