Fujifilm Manufacturing USA, Inc

Sr. Regulatory Affairs Spec

Fujifilm Manufacturing USA, Inc • $106K — $120K *
Santa Ana, CA 92704In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • B.S. or B.A. degree
  • 3-5 years relevant Quality Assurance/Regulatory experience in medical device/pharmaceutical industry
  • Knowledge of GMPs, CFRs, USP, ISO 13485 and quality control methodology
  • Experience in cell and tissue culture or embryology
  • Regulatory Affairs Certificate preferred
  • Proficiency in Microsoft Office and Adobe Acrobat
  • Strong written and verbal English communication skills

Responsibilities

  • Renew and maintain regulatory licensing and registration for local, state, and national levels
  • Identify relevant guidance documents and notify management of updates
  • Assist in preparation of Drug Master Files for FDA, Health Canada, and Japan PMDA
  • Ensure compliance with applicable standards for all processes
  • Communicate with regulatory agencies and authorities regarding global product line requirements
  • Write and revise standard operating procedures and review scientific data
  • Support customers with regulatory filings and provide necessary technical assistance

Benefits

  • Medical, Dental, Vision insurance
  • Life Insurance
  • 401k plan
  • Paid Time Off
Full Job Description
Position Overview

Position Description

We are hiring a Senior Regulatory Affairs Specialist. The Senior Regulator Affairs Specialist will be responsible for providing regulatory support and expertise including but not limited to the following product lines: Cell and Gene Therapy, Bioproduction, recombinant growth factors and Wako Lab Chemicals, Wako endotoxin testing reagents. Assist in the formulation disclosure review process in response to customer requests. Provide support in maintaining required licenses.

Job Description

Responsibilities:
  • Responsible in the renewal and maintenance of, but not limited to, the following:
    • Local, State and National Regulatory licensing and registration renewals
    • Import/Export Permits
  • Assist in the identification of, but not limited to, the following:
    • Relevant guidance documents, international standards, or consensus standards and their interpretation as they relate to registration requirements
    • Notification to management of new and revised documents referenced above
  • Assist in the preparation and maintenance of Drug Master Files that include, but are not limited, to the following:
    • US FDA
    • Health Canada
    • Japan PMDA
  • Ensure compliance of all processes and procedures to applicable standards.
  • Have knowledge of product line requirements worldwide including for Ancillary Materials and Therapies supported by FISI. Communicate with regulatory agencies, notified bodies, and competent authorities.
  • Perform the following activities
    • Write and/or revise standard operating procedures
    • Review and approval of scientific data generated to support claims, warnings and precaution of products
    • Review promotional items and frequently asked questions (FAQ) and answers
    • Support Internal/External and Customer Audits. As needed assist with changes to product design, specifications, or product manufacturing processes
    • Member of the New Product Design Control
    • Assist in Product Recalls
  • Assist in the approval of, but not limited to, the following:
    • Non-conformances
    • CAPA
    • Quality Planning
    • Risk Assessments
    • Document Changes (SOPs, labeling, etc.)
  • Support customers with their regulatory filings and provide technical support as needed
  • Assist in the assessment of Technical Department (R&D) activities that include, but are not limited to, the following:
    • Risk Management File Review and revision based upon complaint
  • Primary back-up to the Senior Manager of Regulatory Affairs
  • Formulation Disclosure:
    • Assist in collecting information to provide to the formulation disclosure review board to support their decision making.
    • Document and track formulation disclosure requests and outcomes.

Required Skills/Education:
  • B.S. or B.A.
  • Three to Five years of direct Quality Assurance and Regulatory experience in the medical device and/or pharmaceutical industry.
  • GMPs, CFRs, USP, ISO 13485Quality control methodology, QA controls systems and production methodologies.
  • Experience in cell, tissues culture and/or embryology. Experience can be from education or industry.
  • Ability to obtain cooperation from other groups and lead cross functional teams.
  • Experience with risk management and Failure Mode Effects Analysis (FMEA).
  • Understanding of validation of processes and equipment, methods validations, process investigations, technical evaluation.
  • Regulatory Affairs Certificate preferred
  • Proficient in Microsoft Word, Excel, PowerPoint, Adobe Acrobat.
  • Ability to write, edit, speak and read English well.

Salary and Benefits:
  • For California, the base salary range for this position is $106,185.25- $120,000. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).
  • Medical, Dental, Vision
  • Life Insurance
  • 401k
  • Paid Time Off

*#LI-onsite

About Fujifilm Manufacturing USA, Inc

Fujifilm Manufacturing USA, Inc is a subsidiary of Fujifilm Holdings Corporation, a Japanese multinational conglomerate that specializes in imaging and photography. Fujifilm Manufacturing USA, Inc is responsible for the manufacturing of photographic paper, film, and other imaging products in the United States. The company was established in 1988 and has its headquarters in Valhalla, New York. Fujifilm Manufacturing USA, Inc operates as a subsidiary of Fujifilm North America Corporation.
Learn more about Fujifilm Manufacturing USA, Inc
Size
72,332 employees
Industry
Manufacturing & Automotive
NASDAQ
FUJIF
* Ladders Estimates

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