Experienced Regulatory Submissions Coordinator

Responsibilities

• Provide day‑to‑day departmental support activities to Regulatory Submissions Coordinators;
• Maintain database and spreadsheets as necessary to facilitate tracking and documentation of departmental activities;
• Collect, review, organize, and assemble regulatory start‑up submissions;
• Perform other tasks as needed.

Additional Responsibilities

• Prepare, review, and file clinical trial applications;
• Communicate with research sites to collect all essential documents required before the site starts to enroll patients;
• Provide insightful input on regulatory submission documents and maintain timelines for study start‑up through both internal and external collaboration;
• Ensure submissions comply with applicable regulations and guidance documents.

Qualifications

• Bachelor’s degree in a Life Sciences field;
• At least 2 years of work experience as a Regulatory Submissions Coordinator;
• Hands‑on experience preparing, reviewing, and submitting regulatory documentation;
• Knowledge of Microsoft Office;
• Excellent organization and communication skills;
• Great attention to detail.

Benefits

• Flexible work environment
• Competitive compensation and benefits package
• Competitive PTO packages
• Structured career paths with opportunities for professional growth
• Company‑sponsored employee appreciation events
• Employee health and wellness initiatives

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