Senior Director, CMC Regulatory Affairs
MDWerks Inc.
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $240,000 - $270,000 per year
Job Level
About the role
- Leading the development, execution, and maintenance of global CMC regulatory strategy to support clinical development, registration, commercialization and lifecycle management of Mineralys products.
- Providing 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.
- Partnering closely with CMC, Quality, and external partners to ensure alignment of CMC documentation, regulatory strategy, product lifecycle planning and management.
Requirements
- 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.
Benefits
- These positions are eligible for 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
CMC regulatory strategyregulatory submissionsglobal regulatory requirementsICH guidelinesregulatory guidancequality management systemsdocumentation management systemspharmaceutical sciencesbiochemistrychemical engineering
Soft Skills
strategic leadershipoperational leadershipcross-functional decision-makinginterpretation of regulatory guidanceability to work in fast-paced environmentresults-focusedteam collaborationcommunication skillsproblem-solvingadaptability
Certifications
MSPhDPharmD