“Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky”
Mineralys is a fully remote company.
The Manager, Regulatory Operations will lead operational planning and execution of global regulatory submissions and maintain the infrastructure, processes, and systems across regulatory operations to ensure high-quality, compliant filings to health authorities. Work cross-functionally to drive submission logistics, document systems, eCTD publishing, and regulatory information management.
Key Responsibilities
Submission Execution & Publishing
- 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.
Process & System Management
- 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.
Cross-Functional Coordination
- 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.
Qualifications
- 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.
Travel
This position is eligible for standard Company benefits including medical, dental, vision, time off and 401K, as well as participating in Mineralys incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring range based on geographic location, work experience, education, and/or skill level.
US Salary Range: $ 130,000 - $145,000
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