Quality Assurance -Supervisor Regulatory Affairs
Quality Assurance -Supervisor Regulatory Affairs
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Job Description
Position Overview
Summary:
The Quality Assurance Regulatory Affairs 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 noneCTD format. Actual work assignments are based on the FUJIFILM Diosynth portfolio of work along with the incumbents experience knowledge demonstrated technical skills and competencies or as part of an individuals 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.
Company Overview
The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in peoples lives. Join FDB and help create 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 FUJIFILM Diosynth Biotechnologies call Genki.
College Station Texas may be a small university town but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of smalltown life and the convenience of living close to the vibrant pulse of big cities. Eightyseven percent of Texas population lives within a 180mile radius so we are in the center of it all in Texas. And our site is nestled in the hub of innovation representing a source of pride for the area.
Job Description
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 presubmission requirements and strategy and to resolve postsubmission 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 eCTD tools
- Effective interpersonal teamwork networking and communication skills.
- Proficiency in applying submissionreadiness 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
- Problemsolving capability including trouble shooting and adaptability required.
- Understanding of the drug development process.
- Skill to apply knowledge of submissionreadiness and publishing standards.
- Cell & Gene Therapy area and product knowledge strong understanding of product development process.
- Ability to read and write in the English language.
- 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.
Minimum Qualifications:
- Bachelors degree or equivalent experience required and minimum of two 2 years of related experience in a regulatory quality or similar position.
- Prior experience working with electronic submission publishing processes and leading eCTD tools.
- Two 2 years of previous leadership experience.
Preferred Qualifications:
- RAP Membership/Certification
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 handeye 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 offshift hours as needed to support manufacturing activities.
- Must be willing to travel occasionally as needed.
- Attendance is mandatory.
EEO Information
Fujifilm is committedto 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 preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department or.
Required Experience:
Manager
Employment Type
Unclear
