Senior Specialist of Regulatory Operations

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Requirements:

• Bachelor's degree (BS/BA) in a scientific discipline preferred; equivalent work experience will be considered.
• 5+ years of industry-related experience in a regulatory publishing function.
• 2+ years of experience working with specialized regulatory submission systems.
• Experience in FDA regulatory submissions for drugs, with familiarity with FDA's electronic submission gateway.
• Knowledge of regulatory requirements related to submissions, particularly in CTD/eCTD format.
• Experience with technical writing is a plus.
• Proficient in software for document formatting and publishing.

Responsibilities:

• Collaborate with Regulatory Leads on submission plans and timelines.
• Perform critical reviews of documents for quality and consistency.
• Format and publish regulatory documents per health authority requirements.
• Maintain regulatory records in controlled systems.
• Contribute to new internal processes for submissions.
• Oversee data migration activities in Regulatory Affairs.
• Stay updated on regulatory submission requirements.
• Support training for end users of regulatory systems.