Manager, Regulatory Operations

Role Overview

• Support regulatory operations and publishing activities, including internal coordination and vendor management, to achieve on-time delivery.
• Coordinate, compile, format, and publish regulatory submissions (e.g., IND/CTA, NDA/MAA, variations, amendments) as needed, ensuring technical compliance with applicable authority requirements.
• Manage quality control reviews of submission deliverables, ensure conformance with company standards, RIM metadata requirements, and regulatory guidelines.
• Coordinate sequencing and gateway testing for electronic filings, resolve technical submission errors and regulatory agency technical requests.
• Drive best practices in document lifecycle management, including version control, archival, and audit preparedness.
• Help maintain and optimize regulatory operations infrastructure, including RIM, templates, and workflow SOPs and WIs.
• Establish and maintain submission and regulatory correspondence trackers, dashboards, and metrics for organizational visibility and audit readiness.
• Drive continuous improvement of regulatory operations processes for efficiency, consistency, and audit readiness.
• Monitor updates to electronic submission standards and implement required changes to processes and tools.
• Interface with Regulatory Affairs, Non-clinical, Clinical, CMC, Quality, and IT etc. to align operational requirements with content strategy and submission timelines.
• Coordinate with internal and external stakeholders (e.g., contractors, publishing vendors) to deliver on operational objectives, quality, and timelines.
• Support readiness for health authority inspections of submission practices and document repositories.
• Assist training in regulatory operations systems, methodologies, requirements and best practices.

Requirements

• Bachelor’s or advanced degrees in Life Sciences, Regulatory Affairs, or related discipline.
• 3 + years of regulatory operations/submissions experience in pharmaceutical or biotech environments, including hands-on publishing and RIM usage.
• Demonstrated knowledge of electronic submission standards (eCTD), metadata, and global regulatory requirements.
• Strong project management, organization, and attention to detail.
• Ability to manage competing deadlines, and work in fast-paced, small-company environment.
• Excellent communication and influencing skills, able to effectively partner with cross-functional teams and external stakeholders.
• Ability to drive process improvements and implement new technologies.

Benefits

• standard Company benefits including medical, dental, vision, time off and 401K
• participating in Mineralys incentive plans are contingent on achievement of personal and company performance