Regulatory Documentation Specialist I

GRIFOLS, S.A. • NC-Clayton, CA

1d • Onsite

About The Position

Maintains regulatory documentation and filing systems in support of the Biopharma North America regulatory team. Maintains accurate files of health authority correspondence in paper and electronic formats as needed and word processing submission documents as needed. This position will support the product managers to meet business objectives for the overall regulatory team.

Requirements

• Basic knowledge of applicable laws and regulations.
• Ability to work with limited supervision and initiate contacts essential to submission preparation.
• Ability to manage multiple and possibly conflicting priorities.
• Ability to work as part of the regulatory team to meet group objectives.
• Ability to review a document in detail to ensure accuracy based on regulatory requirements, and to ensure the use of the appropriate forms, format, content, and authorized signatures.
• Ability to clearly communicate verbally and in writing.
• Ability to effectively use Microsoft Office (particularly Word and Excel) to create, edit, and format documents.
• Ability to work with other computer systems for filing supplements and reports.
• Ability to meet statutory deadlines to ensure compliance, as well as business timelines to accomplish company objectives.

Nice To Haves

• 0 to 1 year of related technical and/or regulatory experience in pharmaceutical or blood industry or an equivalent combination of education and experience.

Responsibilities

• Perform updates, facilitate SME reviews, and ensure proper hard copy and electronic filing of Regulatory Submission Documents (RSDs) as needed.
• Ensure that regulatory records are properly filed and accessible in the appropriate documentation system.
• Assist in maintaining SOPs/IBPs that describe the Regulatory Affairs filing system and other RA SOPs/IBPs files and maintenance.
• Manage requests for translations and legalizations with vendors.
• Respond to requests for records by researching and reviewing internal documentation, including the retrieval of documents from off-site storage.
• Communicate with regulatory personnel regarding regulatory records.
• Process and track all invoices to ensure prompt payment.
• Request Certificate of Foreign Governments (CFG) and Certificate of Pharmaceutical Products (CPP) from FDA
• Serve as primary contact with Accounts Payable.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level