Regulatory Operations Manager (Submission Delivery)

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

Job summary

A leading pharmaceutical company is seeking a Regulatory Operations Manager to manage eCTD submissions. This remote role involves overseeing publishing deliverables, ensuring compliance with regulatory standards, and acting as the primary regulatory contact throughout the product lifecycle.

Benefits

Medical Insurance

Vision Insurance

Responsibilities

• Coordinating all publishing deliverables according to strategic program directions.
• Overseeing outsourced publishing activities to ensure successful execution.
• Managing hand-offs from the authoring team to meet quality and timing 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, with details as follows:

• Pay: $60.00-65.77/hr
• Duration: 1 year with potential extension
• Location: Remote, must reside on East or Central coast

The role involves managing eCTD submissions across the company's product portfolio to health authorities for global development and lifecycle management. Responsibilities include:

• Coordinating all publishing deliverables according to strategic program directions
• Overseeing outsourced publishing activities to ensure successful execution
• Acting as the primary regulatory contact during the product lifecycle
• Ensuring submission deliverables are accessible to stakeholders
• Managing hand-offs from the authoring team to meet quality and timing standards
• Driving timelines with the Regulatory Submission Manager and setting quality expectations
• Ensuring electronic submissions meet regulatory and technical standards

Additional Details

• Seniority Level: Mid-Senior level
• Employment Type: Contract
• Job Function: Other
• Industry: Pharmaceutical Manufacturing

Benefits inferred include medical and vision insurance. Notifications about similar roles are available in the United States, with salary ranges from $70,000 to over $200,000 depending on the location and role. This description focuses solely on the job responsibilities and requirements relevant to the position, avoiding irrelevant or promotional content.