Regulatory Operations Manager

Regulatory Operations Manager

Remote EST Hours

Job Summary: The Regulatory Operations Manager coordinates and oversees the publishing of deliverables for electronic submissions to health authorities, ensuring compliance with submission standards and regulations. They act as the primary regulatory contact, managing timelines, and ensuring quality standards are met throughout the product lifecycle. The role also involves vendor oversight and quality control of submission-related documents and tools.

• Manage eCTD submission deliverables for global regulatory submissions, ensuring compliance with standards and timelines.
• Oversee and coordinate publishing activities with internal teams and external vendors to ensure successful submission execution.
• Perform quality control checks on electronic submissions, ensuring adherence to health authority regulations and submission guidelines.

• 3-5 years of regulatory operations experience with submission delivery support for the US and Europe.
• Experience overseeing publishing vendors and familiarity with submission publishing tools preferred.
• Strong knowledge of submission guidelines, eCTD components, and health authority regulations for US and Europe.

• Remote (EST Hours)

• Mid-Senior level

• Contract

• Administrative