Regulatory Operations Manager (Submission Delivery)

The Fountain Group; Illinois; Hybrid; Full time

Job summary

A prominent pharmaceutical client is seeking a Regulatory Operations Manager (Submission Delivery) for a remote position. The role involves managing eCTD submissions, coordinating publishing deliverables, and ensuring compliance with submission standards. Ideal candidates will have experience in regulatory operations and be based in the US.

Responsibilities

• Manage eCTD submissions for global health authority submissions.
• Coordinate publishing deliverables and oversee outsourced publishing.
• Serve as primary contact for regulatory functions.

Job description

Job Title: Regulatory Operations Manager (Submission Delivery)

We are currently seeking a Regulatory Operations Manager (Submission Delivery) for a prominent Pharmaceutical client. This position is Remote. Details are as follows:

1. Pay: $60.00-65.77/hr
2. Duration: 1 year with potential for extension
3. Location: 100% remote; must reside on East or Central coast
4. Timezone: US-based, preferred EST, possibly Central, not West Coast
5. Responsibilities:

• Manage eCTD submissions across the product portfolio for global health authority submissions during development and lifecycle management.
• Coordinate all publishing deliverables aligned with strategic program directions. Oversee outsourced publishing to ensure timely and quality execution.
• Serve as the primary contact for regulatory functions throughout the product lifecycle.
• Ensure submission deliverables are accessible to all stakeholders.
• Manage hand-offs from the authoring team, ensuring compliance with submission standards and quality expectations.
• Drive submission timelines in collaboration with the Regulatory Submission Manager and authoring teams, maintaining standards of quality.
• Ensure electronic submissions meet regulatory agency standards and technical requirements.