Director of Submission Operations Management - Remote

Overview

The Director of Submission Operations Management will lead the submission teams for regulatory Health Authority reviews across multiple regions, ensuring compliance and efficiency in the submission process while fostering collaboration across various functional areas.

In Short

• Manage submission teams for North America, Latin America, EEA, Middle East, and Africa.
• Ensure compliance with regulatory submission standards and timelines.
• Provide leadership and direction to Regulatory Submissions Operations Management teams.
• Collaborate with internal stakeholders and negotiate with regulatory affairs teams.
• Monitor ongoing projects and report status updates to management.
• Engage with health authorities on electronic submission requirements.
• Utilize strong project management skills to guide submission processes.
• Ensure electronic archiving of submissions is accessible for audits.
• Manage external vendors and ensure clarity on expectations.
• Support training and enhancements of regulatory systems.

Requirements

• Minimum of 10 years of Regulatory Operations experience.
• At least 6 years in a regulatory operations leadership role.
• Bachelor’s degree required; Master’s in Regulatory Affairs is a plus.
• Expert in Microsoft Office Suite and eCTD publishing software.
• Experience with document management systems.
• Strong communication and negotiation skills.
• Ability to lead and manage teams effectively.
• Experience in the pharmaceutical and biotechnology industry.
• Knowledge of regulatory compliance and audit requirements.
• Willingness to travel less than 20% of the time.

Benefits

• Comprehensive benefits package including Medical, Dental, and Vision.
• 401(k) with company match.
• Paid Time Off and Wellness programs.
• Opportunity for equity awards.
• Incentive compensation for Commercial roles.