Regulatory Affairs Specialist - Vista, CA

Regulatory Affairs Specialist

Location:

Vista, CA

Contract Type:
Regular Full-Time

Area:
Manufacturing

This position is 100% on-site at our Vista, CA facility.

Summary:

This position is responsible for handling time‑sensitive regulatory documents in accordance with appropriate regulatory agencies and internal company procedures. It will maintain documentation and files including: facility licensure, error & accident (deviation) reports, deferred donor list (DDL), viral marker data forms, monthly plasma yields spread sheet, PPTA epidemiology data spreadsheet, doctor, manager, and physician substitute approval letters, final disposition of units, and recalls.

• Administrate error and accident (deviation) procedure and process; perform data entry, paperwork, file maintenance, written and verbal communications, and follow up within required time constraints.
• Oversight of data entries in the GBS DDL.
• Assist Regulatory Management with product deviation reporting to the FDA.
• Update and distribute annual facility FDA reports.
• Assist with regulatory submissions, annual reports, and regulatory responses.
• Assure maintenance of registrations, including renewals, site registrations, and supplements for change.
• Assist with compiling and submitting reportable events.
• Support regulatory agency audits.
• Assist with review of product labels and commercial materials to prevent non‑compliance findings.
• Receive and review monthly viral marker data information, maintain associated files, perform data entry, and follow up with centers as needed.
• Create, review, and mail doctor, manager, and physician substitute approval letters. Maintain associated files.
• Help management ensure compliance with FDA regulations and all policies, guidelines, and SOPs related to deviation management.
• Maintain updated CFR access for donor center and manufacturing operations.
• Coordinate deviation management process to ensure timely reporting and closure for GBS whole blood, source plasma, and manufacturing operations.
• Coordinate the recall procedure and process, contact centers for recall documentation, and coordinate customer communications with Customer Support for final disposition of product.
• Receive and review data for Look Back Reports and Post Donation Information Reports; generate and prepare associated customer notifications.
• Perform review of deviation reports and associated documentation to ensure completeness, including documented evidence of impact assessments as part of risk management and completion of all CAPA actions required by the report.
• Coordinate training on deviation management procedures.
• Maintain a master library/database of all deviation documents.
• Maintain a secured filing and storage system for archived hard copies of deviation reports.
• Prepare/prove document content and formatting for all deviation reports.
• Coordinate with document authors, owners, and reviewers to resolve content and formatting.
• Maintain a master library / database of all SOPs, forms, job aids, and training documents.
• Maintain a secured filing and storage system for archived hard copy / controlled documentation.
• Perform additional duties as assigned by management.

• 5‑10% travel.
• Intermediate to advanced computer skills in Microsoft Word, Outlook, Excel.
• Cell therapy or cell culture experience highly preferred.
• Advanced understanding of GMPs, FDA & EU regulatory requirements.
• Excellent interpersonal and communication skills.
• Must possess customer service skills and display attention to detail.
• Experience with deviation management system a plus.
• Must be flexible and able to multi‑task in a fast‑paced environment and be a team player.
• Must be able to proof work and identify non‑standard format or wording and errors within documents.
• Associate degree or equivalent.

The estimated pay scale for the Regulatory Affairs Specialist role based in California is $80,546.00 – $ per year. The position is eligible to participate in up to 5% of the company bonus pool and offers medical, dental, vision, life insurance, PTO, paid holidays, up to 5% 401(k) match, and tuition reimbursement. Compensation packages depend on education, experience, skillset, knowledge, role location, internal equity, and market data.

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, sex, gender identity, sexual orientation, religious practices and observances, national origin, pregnancy, childbirth, or related medical conditions, status as a protected veteran or spouse/family member of a protected veteran, or disability. We consider employment qualified applicants in a manner consistent with applicable laws, including the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance, and the City of Los Angeles Fair Chance Initiative.