Sr. Regulatory Affairs Spec

About the Role

The Senior Regulatory Affairs Specialist will provide regulatory support and expertise for product lines including Cell and Gene Therapy, Bioproduction, recombinant growth factors, Wako Lab Chemicals, and Wako endotoxin testing reagents. This role assists in the formulation disclosure review process in response to customer requests and provides support in maintaining required licenses.

Key Responsibilities

• Responsible for renewal and maintenance of Local, State and National Regulatory licensing and registration renewals, and Import/Export Permits
• Assist in identification of relevant guidance documents, international standards, or consensus standards and their interpretation as they relate to registration requirements; notify management of new and revised documents
• Assist in preparation and maintenance of Drug Master Files for US FDA, Health Canada, and Japan PMDA
• Ensure compliance of all processes and procedures to applicable standards; maintain knowledge of product line requirements worldwide including for Ancillary Materials and Therapies supported by FISI
• Communicate with regulatory agencies, notified bodies, and competent authorities
• 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 team
• Assist in Product Recalls
• Assist in approval of Non-conformances, CAPA, Quality Planning, Risk Assessments, and Document Changes (SOPs, labeling, etc.)
• Support customers with their regulatory filings and provide technical support as needed
• Assist in assessment of Technical Department (R&D) activities including Risk Management File review and revision based upon complaint
• Serve as primary back-up to the Senior Manager of Regulatory Affairs
• Assist in collecting information for formulation disclosure review board, document and track formulation disclosure requests and outcomes

Qualifications

• B.S. or B.A. degree
• Three to Five years of direct Quality Assurance and Regulatory experience in the medical device and/or pharmaceutical industry
• Knowledge of GMPs, CFRs, USP, ISO 13485
• Knowledge of quality control methodology, QA controls systems and production methodologies
• Experience in cell, tissues culture and/or embryology (education or industry experience accepted)
• 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, and technical evaluation
• Regulatory Affairs Certificate preferred
• Proficient in Microsoft Word, Excel, PowerPoint, Adobe Acrobat
• Ability to write, edit, speak and read English well

Pay

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.).

Benefits

• Medical, Dental, Vision
• Life Insurance
• 401k
• Paid Time Off