Regulatory Submission Publishing Specialist

Proficiency with Microsoft Word, Adobe Acrobat Pro, ISI Toolbox, Veeva RIMS, US Health Authority portals, and other publishing tools. Coordinate with Regulatory Affairs teams and project stakeholders to ensure timely submissions.

The Science Team at Pride Health is hiring a "Regulatory Submission Publishing Specialist" for a top biotechnology company. 

Key Responsibilities

• Prepare, publish, and submit regulatory dossiers for FDA and EU regulatory agencies.
• Format and compile submission documents in accordance with health authority guidelines.
• Coordinate with Regulatory Affairs teams and project stakeholders to ensure timely submissions.
• Track submission timelines, maintain publication records, and support document repositories.
• Ensure submission quality, accuracy, and compliance with regulatory standards.

Qualifications

• Bachelor's degree in Life Sciences, Regulatory Science, Quality, or equivalent experience.
• 5+ years of regulatory submission publishing experience in the pharmaceutical, biotech, or diagnostics industry.
• Experience with FDA, EMA, ICH, and GxP regulatory requirements.
• Proficiency with Microsoft Word, Adobe Acrobat Pro, ISI Toolbox, Veeva RIMS, US Health Authority portals, and other publishing tools.

Additional Information:

• Duration: 1-year contract (potential for extension)
• Location: 100% Remote
• Schedule: Part-time (24–32 hours/week) with flexible workdays
• Pay range: $30-35hr. on W2

Must be authorized to work in the United States. 

 
APPLY NOW!
 
Pride Global and its affiliates, including Russell Tobin, Pride Health, Pride Now, and Pride One, offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, auto, home insurance, pet insurance and employee discounts with preferred vendors.

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