Senior Regulatory Submissions Manager - Remote

Overview

The Senior Regulatory Submissions Manager will oversee the operational aspects of all submissions to U.S. and international Regulatory Agencies, ensuring high-quality and timely submissions.

In Short

• Manage planning, tracking, and coordinating of regulatory submissions.
• Ensure compliance with U.S. and international regulatory requirements.
• Create and manage submission content plans.
• Publish and validate eCTD submissions.
• Track regulatory commitments for assigned products.
• Coordinate development of submission deliverables.
• Communicate with functional authors for timely document acquisition.
• Oversee writing and implementation of standards for regulatory documentation.
• Develop best practices for electronic submissions.
• Serve as a contact for electronic document management systems.

Requirements

• BS or BA in a scientific or relevant technical discipline.
• 5+ years of experience in pharmaceutical or biotech industry.
• Experience with regulatory operations and submissions.
• Proficiency in Microsoft Word, Adobe Acrobat, and electronic publishing software.
• Knowledge of eCTD and submission publishing tools.
• Ability to work in a fast-paced, dynamic environment.
• Strong organizational and communication skills.
• Ability to adhere to project timelines and budgets.

Benefits

• 99% premium cost covered for medical, dental, and vision plans.
• Bonus program structured to pay quarterly.
• 401k plan with 100% match up to 6% of contributions.
• Wellness benefit of $200/month.
• Unlimited PTO and generous family leave benefits.
• Eligibility for equity awards and Employee Stock Purchase Plan.