“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 Senior Director, CMC (Chemistry, Manufacturing, and Controls) Regulatory is responsible for leading the development, execution, and maintenance of global CMC regulatory strategy to support clinical development, registration, commercialization and lifecycle management of Mineralys products. This role provides strategic and operational leadership for all CMC-related regulatory activities, supporting cross-functional decision-making by providing regulatory guidance, ensuring compliance of CMC documentation and high-quality submissions that meet global regulatory requirements and support business objectives. The Sr. Director partners closely with CMC, Quality, and external partners to ensure alignment of CMC documentation, regulatory strategy, product lifecycle planning and management.
Key Responsibilities
Strategic Leadership
- 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.
Regulatory Submissions & Lifecycle Management
- 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.
Cross-Functional Collaboration
- 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.
Process & Best Practices
- 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.
Qualifications
Education
- Advanced degree (MS, PhD, PharmD) in Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or related scientific discipline; Bachelor’s degree with extensive experience acceptable.
Experience
- 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.
Core Competencies
- Strategic Planning
- Regulatory Risk Assessment & Management
- Project & Time Management
- Stakeholder Engagement
- Cross-Functional Collaboration & Influence
- Excellent Communication Skills
Travel
- This position requires up to 20% travel. Frequently travel is outside the local area and overnight.
These positions are 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: $240,000 - $270,000
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