Regulatory Affairs Specialist - Vista, CA

Summary

This position is responsible for handling time-sensitive Regulatory documents in accordance with appropriate regulatory agencies and internal company procedures. This includes maintaining documentation and files such as 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.

Primary Responsibilities

• Administrate Error and Accident (Deviation) procedure and process; perform all required data entry, paperwork, file maintenance, written and verbal communications, and follow up within the required time constraints.
• Oversight of data entries in the GBS DDL.
• Aid Regulatory Management with product deviation reporting to the FDA.
• Updates and distributes annual facility FDA reports.
• Aids with regulatory submissions, annual reports, and regulatory responses.
• Assures that appropriate maintenance of registrations occurs including renewals, site registrations, supplements for change, assists with compiling and submitting reportable events, support regulatory agency audits, assist with the review of product labels and commercial materials to prevent findings of non-compliance.
• 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 Food and Drug Administration (FDA) regulations and all policies, guidelines, and standard operating procedures (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.
• Cook recalls, contact centers for recall documentation, 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 a part of risk management and completion of all CAPA actions required by the report have occurred.
• Cook training on deviation management procedures.
• Maintain a master library/database of all Deviation documents.
• Maintain secured filing and storage system for archived hard copies of Deviation Reports.
• Prepare/proofs document content and formatting for all Deviation Reports.
• Cook 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 secured filing and storage system for archived hard copy / controlled documentation.

Additional Responsibilities, Skills & Education

• 5-10% Travel.
• Intermediate to advanced computer skill in Microsoft Word, Outlook, Excel.
• Cell Therapy or Cell Culture experience highly preferred.
• Advanced understanding of Good Manufacturing Practices (GMPs), FDA & EU Regulatory requirements.
• Excellent interpersonal and communication skill.
• 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 team player.
• Must be able to proof work and identify non-standard format or wording and errors within documents.

Qualifications

• Associates degree or equivalent.

Pay & Benefits

The estimated pay scale for the Regulatory Affairs Specialist role based in California, is $80,546.00 - $120,819.00 per year. Additionally, the position is eligible to participate in up to 5% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, life insurance, PTO, paid holidays and up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!