Regulatory Operations Manager

GForce Life Sciences; United States; Remote; USD 70,000 - 100,000; Part time

Job summary

A leading life sciences company is seeking a Regulatory Operations Manager to oversee the publishing of deliverables for electronic submissions to health authorities. The role involves vendor oversight, quality control of submission-related documents, and ensuring compliance with submission standards and regulations. Candidates should have 3-5 years of regulatory operations experience, particularly in the US and Europe. This is a remote position requiring expertise in compliance and submission guidelines.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Regulatory operations experience

Knowledge of submission guidelines

Quality control

Vendor oversight

Job description

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.

Responsibilities

• 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.

Qualifications

• 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.

Terms

• Remote (EST Hours)

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Administrative