Regulatory Document Control & Quality Specialist

CICONIX; Frederick (MD); On-site; USD 55,000 - 58,000; Full time

Benefits offered by this job

Health benefits

PTO

401k + contribution

Job summary

CICONIX is seeking a Document Control and Quality Specialist to support the Office of Regulated Activities for the DHA R&D MRDC team in Fort Detrick, MD. You will prepare, publish, and submit documents in accordance with laws, regulations, and policies for drug, biologic, device, and combination products; provide document control and archiving support for electronic and paper records.

The role requires publishing dossiers to regulatory formats, ensuring audit-ready files, and offering

Qualifications

• 5 years of administrative experience.
• Proficient with Microsoft Word, PowerPoint, Excel, and Outlook.
• Ability to manage and digitize paper records up to 25 lbs.
• U.S. Citizenship with ability to obtain government security clearance.

Responsibilities

• Prepare documents for publishing and regulatory submission in required formats (eCTD, eSTAR, etc).
• Publish dossiers meeting applicable regulations and meet tight deadlines; provide validation reports.
• Perform quality reviews and provide feedback on published dossiers.
• Submit dossiers to the US FDA via the Electronic Submission Gateway and other methods.
• Create and maintain audit-ready regulatory files and Trial Master File (TMF).
• Maintain Sponsor Regulatory Mailbox and upload documents to SERF in the EDMS.

Skills

Administrative experience

Regulatory knowledge

Attention to detail

Communication

Tools

Microsoft Word

PowerPoint

Excel

Outlook

EDMS

Job description

CICONIX is seeking a Document Control and Quality Specialist to support the Office of Regulated Activities for the DHA R&D MRDC team in Fort Detrick, MD. You will prepare, publish, and submit documents in accordance with laws, regulations, and policies for drug, biologic, device, and combination products; provide document control and archiving support for electronic and paper records.

The role requires publishing dossiers to regulatory formats, ensuring audit-ready files, and offering