Associate Director Regulatory Operations Submission Manager - Remote

Overview

The Senior Manager/Associate Director Regulatory Operations Submissions Manager will report to the Director of Regulatory Operations. This position will partner with Regulatory Affairs and collaborate with cross-functional Subject Matter Experts as the department expands submission management capabilities.

In Short

• Key leadership role in newly formed Global Regulatory Submission Team.
• Collaborate with regulatory strategists and cross-functional SMEs.
• Develop, manage, and implement agile regulatory project management tools.
• Monitor progress, evaluate timelines, schedules, and risks.
• Migrate historical documents into Veeva RIMS.
• Represent the regulatory operations function on cross-functional teams.
• Contribute to ongoing process improvement and department initiatives.
• Proactively communicate and coordinate resource allocation.
• Review project related plans for best practices.
• Skilled in utilizing eCTD publishing tools.

Requirements

• Bachelor's Degree preferred with ability to understand scientific principles.
• 6+ years of industry experience in regulatory information management.
• Veeva RIM Vault experience highly preferred.
• Proficient in Microsoft 365 Suite and experienced with virtual platforms.
• Significant experience in global drug development regulations.
• At least two marketing application submissions in the USA or more jurisdictions.
• Understanding of regulatory standards/requirements.
• Excellent organizational skills and attention to detail.
• Ability to prepare documents for regulatory submission.
• Demonstrated ability to develop, execute, and follow-through complex projects.

Benefits

• Base salary range of $171,000 - $189,000.
• Competitive compensation and benefits including bonuses and stock options.
• 401(k) with an employer match.
• Comprehensive wellness program including medical, dental, and vision coverage.
• Four weeks of time off.
• Commitment to learning and development with various programming.