Regulatory Affairs Operations Manager

Remote, EST hours

Schedule: Standard Office Hours

Duration: 12-Month Contract

Pay: $58-63/ph

Job Responsibilities:

In this role, you will manage eCTD submission activities across a global product portfolio, supporting both development and lifecycle management submissions to Health Authorities for a leading biotech company. Key responsibilities include:

• Coordinating all publishing deliverables in alignment with program strategies.
• Overseeing outsourced publishing teams to ensure timely and accurate execution of operational activities.
• Acting as the primary point of contact for regulatory functions throughout the product lifecycle.
• Driving submission timelines and ensuring deliverables meet internal standards and Health Authority requirements.
• Supporting submission readiness by coordinating with content authors and submission managers.

Essential Duties and Job Functions:

• Manage electronic submission planning and delivery for assigned products.
• Ensure deliverables from the authoring community are timely and meet submission quality standards.
• Monitor and manage outsourced publishing activities on a day-to-day basis.
• Perform quality control checks on eCTD components, including hyperlinks and bookmarks.
• Ensure all submissions meet local regulatory guidelines and technical specifications.
• Maintain visibility of submission deliverables to all stakeholders.
• Demonstrate expert understanding of Health Authority submission requirements and regulatory technologies.
• Utilize electronic document management and publishing tools effectively.

Knowledge & Skills:

• Strong knowledge of Health Authority submission formats and guidelines.
• Proficient in electronic publishing and document management systems.
• Excellent coordination, communication, and organizational skills.
• Ability to manage multiple projects and timelines simultaneously.
• Familiarity with quality control standards for regulatory submissions.

Education & Experience:

• 3-5 years of experience in regulatory operations, supporting US and EU submission delivery.
• Experience overseeing publishing vendors is preferred.