Regulatory Submissions Lead (Remote EST)

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

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.