Sr. Regulatory Affairs Spec

Merck & Co.; Santa Ana (CA); On-site; USD 106,000 - 120,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Life Insurance

401k

Paid Time Off

Job summary

FUJIFILM Biosciences in Santa Ana, CA, seeks a Senior Regulatory Affairs Specialist to manage licenses, filings, and regulatory support across cell/gene therapy, bioproduction, and related materials.

You will review and prepare regulatory documents, coordinate with agencies, and ensure compliance with global standards while supporting audits and product changes. This role anchors the regulatory function within the team.

Qualifications

• B.S. or B.A. degree required.
• 3–5 years direct QA & regulatory experience in medical device/pharma.
• GMPs, CFRs, USP, ISO 13485 quality control methods and production.
• Experience in cell, tissues culture and/or embryology.
• Ability to lead cross-functional teams and obtain cooperation.
• Experience with risk management and FMEA.
• Regulatory Affairs Certificate preferred.
• Proficient in Word, Excel, PowerPoint, Adobe Acrobat.
• Ability to write, edit, speak and read English well.

Responsibilities

• Renewal and maintenance of local, state and national regulatory licensing and registrations.
• Identify guidance documents, international standards, and interpret them for registration.
• Prepare and maintain Drug Master Files (US FDA, Health Canada, PMDA).
• Ensure compliance of processes and procedures to applicable standards.
• Know product line requirements worldwide; communicate with regulatory agencies and authorities.
• Write/revise SOPs; review data, claims, warnings, and FAQs.
• Support audits; assist with product/design changes and recalls.
• Assist in CAPA, non-conformances, risk assessments, and document changes.
• Back-up to Senior Manager of Regulatory Affairs.
• Support formulation disclosure reviews and track outcomes.

Skills

Regulatory Affairs

Risk Management

FMEA

Cross-Functional Team Leadership

Process Validation

Documentation & SOPs

GMPs/CFRs

English Proficiency

Education

B.S./B.A.

Regulatory Affairs Certificate (preferred)

Tools

Microsoft Word

Excel

PowerPoint

Adobe Acrobat

Job description

Position Overview

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.

Position Description

At FUJIFILM Biosciences, we turn curiosity into breakthroughs that advance the field of life sciences. By offering a comprehensive portfolio of products and services in cell culture media, discovery research reagents, recombinant growth factors and proteins, fine chemicals, and critical assay materials, we partner with the brightest minds in biotech and pharma to tackle the world's biggest health challenges.

Company Overview

Imagine being part of a team that enables life-changing discoveries like new vaccines, therapies, and advancements in regenerative medicine. Our culture fosters curiosity, collaboration, and innovation, and we pride ourselves on delivering unparalleled quality and service to our partners. If you're ready to make an impact, your future belongs with us at FUJIFILM Biosciences.

Our headquarters in Santa Ana, California, is surrounded by world-class schools, lush parks, and scenic beaches like Laguna and Huntington, making it an ideal place to live, work, and explore. With additional campuses across the US, Europe, China, and Japan, we offer opportunities to make a difference worldwide.

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

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

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]).