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.
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