Regulatory Affairs Operations Managers

Summary: The Regulatory Affairs Operations Manager will oversee eCTD submission activities for a leading biotech company, ensuring compliance with Health Authority requirements. This role involves managing publishing deliverables, coordinating with various stakeholders, and maintaining submission quality standards. The position is remote and operates on Eastern Standard Time, with a contract duration of 12 months.

Key Responsibilities:

• 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.
• Managing electronic submission planning and delivery for assigned products.
• Ensuring deliverables from the authoring community are timely and meet submission quality standards.
• Monitoring and managing outsourced publishing activities on a day-to-day basis.
• Performing quality control checks on eCTD components, including hyperlinks and bookmarks.
• Ensuring all submissions meet local regulatory guidelines and technical specifications.
• Maintaining visibility of submission deliverables to all stakeholders.
• Demonstrating expert understanding of Health Authority submission requirements and regulatory technologies.
• Utilizing electronic document management and publishing tools effectively.

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

Salary (Rate): 46.00

City: Boston

Country: United States

Working Arrangements: remote

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other