Senior Director, CMC Regulatory Affairs
Scorpion Therapeutics, New Bremen, Ohio, United States
Role Summary
Senior Director, CMC Regulatory Affairs leads the global CMC regulatory strategy to support clinical development, registration, commercialization, and lifecycle management of Mineralys products. The role provides strategic and operational leadership for all CMC regulatory activities, guiding cross-functional decision-making, ensuring compliant CMC documentation, and producing high-quality submissions that meet global regulatory requirements. The incumbent partners closely with CMC, Quality, and external partners to align documentation, regulatory strategy, and lifecycle planning. 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. 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 and documentation management systems. Ability to work effectively in a fast-paced and results-focused environment and on matrix teams.
Skills
Strategic Planning Regulatory Risk Assessment & Management Project & Time Management Stakeholder Engagement Cross-Functional Collaboration & Influence Excellent Communication Skills Additional Requirements
Travel: This position requires up to 20% travel; frequently travel outside the local area and overnight.
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Senior Director, CMC Regulatory Affairs leads the global CMC regulatory strategy to support clinical development, registration, commercialization, and lifecycle management of Mineralys products. The role provides strategic and operational leadership for all CMC regulatory activities, guiding cross-functional decision-making, ensuring compliant CMC documentation, and producing high-quality submissions that meet global regulatory requirements. The incumbent partners closely with CMC, Quality, and external partners to align documentation, regulatory strategy, and lifecycle planning. 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. 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 and documentation management systems. Ability to work effectively in a fast-paced and results-focused environment and on matrix teams.
Skills
Strategic Planning Regulatory Risk Assessment & Management Project & Time Management Stakeholder Engagement Cross-Functional Collaboration & Influence Excellent Communication Skills Additional Requirements
Travel: This position requires up to 20% travel; frequently travel outside the local area and overnight.
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