Mineralys Therapeutics, Inc. · 23 hours ago
Manager, Regulatory Operations
United States
Full-time
Remote
Mid Level
$130K/yr - $145K/yr
3+ years expMineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines for hypertension and related conditions. The Manager, Regulatory Operations will lead the planning and execution of global regulatory submissions and maintain the necessary infrastructure to ensure compliant filings with health authorities.
BiopharmaBiotechnologyMedicalPharmaceutical
Responsibilities
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
Qualification
Required
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
Medical
Dental
Vision
Time off
401K
Company
Mineralys Therapeutics, Inc.
At Mineralys Therapeutics we aim to redefine hypertension diagnosis, management and treatment.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$740.5MKey Investors
TCG CrossoverAndera Partners,RA Capital ManagementHBM Healthcare Investments,Samsara BioCapital
2025-09-02Post Ipo Equity· $287.5M
2025-03-11Post Ipo Equity· $175M
2024-02-08Post Ipo Equity· $120M
Leadership Team
David Rodman
Chief Medical Officer
Erin Gillin
Executive Assistant To Chief Executive Officer
Recent News
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