Regulatory Operations Manager (Submission Delivery)

The Fountain Group; Illinois; Remote; USD 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical client is seeking a Regulatory Operations Manager (Submission Delivery) for a remote position. The role involves managing eCTD submissions, coordinating deliverables, and ensuring compliance with regulatory standards. This entry-level contract position offers a competitive hourly rate and the opportunity to work within a dynamic team in the IT Services and Consulting industry.

Responsibilities

• Manage eCTD submissions across the product portfolio for global health authority submissions.
• Coordinate publishing deliverables, ensuring alignment with strategic program goals.
• Act as the primary regulatory contact during the product lifecycle.
• Ensure submission deliverables are accessible to stakeholders and meet quality standards.
• Manage timelines with the Regulatory Submission Manager and authoring teams.
• Oversee electronic submissions, ensuring compliance with regulatory standards.

Job description

Regulatory Operations Manager (Submission Delivery)

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

• Pay: $60.00-65.77/hr
• Assignment Duration: 1 year with potential extension
• Location: Remote, must reside on East or Central coast, US-based (EST preferred)

Job Responsibilities:

• Manage eCTD submissions across the product portfolio for global health authority submissions.
• Coordinate publishing deliverables, ensuring alignment with strategic program goals.
• Act as the primary regulatory contact during the product lifecycle.
• Ensure submission deliverables are accessible to stakeholders and meet quality standards.
• Manage timelines with the Regulatory Submission Manager and authoring teams.
• Oversee electronic submissions, ensuring compliance with regulatory standards.

Additional Details:

• Seniority Level: Entry level
• Employment Type: Contract
• Job Function: Other
• Industries: IT Services and IT Consulting