Mineralys Therapeutics, Inc. · 11 hours ago
Senior Director, CMC Regulatory Affairs
United States
Full-time
Remote
Director/Executive
$240K/yr - $270K/yr
10+ years expMineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines for hypertension and related comorbidities. The Senior Director, CMC Regulatory Affairs, is responsible for leading the global CMC regulatory strategy to support the development, registration, and lifecycle management of products, ensuring compliance and alignment with business objectives.
BiopharmaBiotechnologyMedicalPharmaceutical
Responsibilities
Develop and implement global CMC regulatory strategies aligned with clinical development, manufacturing, commercialization, and other business objectives
Provide regulatory intelligence on global CMC requirements and emerging regulatory trends
Represent the company in regulatory agency interactions and strategic meetings on CMC related topics
Oversee preparation, review, and approval of CMC components in regulatory submissions (IND/CTA, NDA/MAA, post-approval lifecycle management)
Advise all CMC related functions (Process Development, Analytical Development, Quality Control) on the preparation of IND/CTA and NDA/MAA dossiers to ensure timely delivery of quality documents for submission
Liaise with global regulatory authorities as needed for all CMC aspects pertaining to drug development including resolution of key regulatory issues
Lead CMC responses to regulatory agency inquiries and deficiency letters
Serve as CMC RA subject matter expert in cross-functional project teams (R&D, Quality, Manufacturing, Supply Chain)
Provide counsel, training, and interpretation of FDA and other regulatory guidance to company personnel
Build partnerships and foster collaboration with key stakeholders to ensure business goals are met
Guide integration of CMC regulatory considerations early in development and manufacturing decisions
Provide regulatory impact assessments and guidance for manufacturing changes, technology transfers, and lifecycle initiatives
Provide CMC review/input for clinical study protocols, investigator brochures, and other relevant reports
Establish and maintain CMC RA procedures and best practices to support submission readiness and compliance
Develop processes, systems, and infrastructure to assure CMC regulatory compliance
Monitor new regulations, guidance and interpret impact on company programs
Qualification
Required
Advanced degree (MS, PhD, PharmD) in Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or related scientific discipline; Bachelor's degree with extensive experience acceptable
Minimum 10 + years of pharmaceutical/biotech experience with 8 + years CMC regulatory experience
Proven record of leading global CMC strategy, submission, and agency interactions (FDA, EMA, PMDA etc.) in both pre- and post-marketing settings
Strong knowledge of global CMC regulatory requirements, ICH guidelines, and submission standards
Demonstrated ability to interpret and apply regulatory guidance to complex CMC issues and lifecycle activities
Experience with regulatory submission management tools and electronic submission systems
Solid understanding of quality management systems including change controls, documentation management systems
Ability to work effectively in a fast-paced and results-focused environment and on matrix teams
Strategic Planning
Regulatory Risk Assessment & Management
Project & Time Management
Stakeholder Engagement
Cross-Functional Collaboration & Influence
Excellent Communication Skills
Benefits
Medical
Dental
Vision
Time off
401K
Participating in Mineralys incentive plans
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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