Senior Director, CMC Regulatory Affairs
Praxis
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $260,000 - $283,000 per year
Job Level
About the role
- Develop and lead global Regulatory CMC strategies for investigational and commercial small molecule and ASO products, aligned with development, manufacturing, and commercialization objectives.
- Serve as the Regulatory CMC subject matter expert, providing strategic guidance on regulatory risks, timelines, and mitigation plans across the product lifecycle.
- Ensure strong cross-functional partnership and alignment with Quality, Analytical, Development, Supply Chain and Commercial Manufacturing teams to support integrated CMC planning and execution.
- Author and oversee preparation, review, and submission of CMC sections for INDs, IMPDs, NDAs, and post-approval supplements, ensuring consistency, quality, and regulatory compliance.
- Lead and support CMC-related interactions with global health authorities (e.g., FDA, EMA), including meeting strategy, briefing materials, and responses to regulatory inquiries.
- Provide regulatory oversight for clinical and commercial manufacturing, including process validation, control strategies, stability programs, and supply continuity.
- Lead CMC regulatory strategies for post-approval changes, comparability assessments, technology transfers, and manufacturing site changes.
- Build and manage internal Regulatory CMC capabilities and oversee external consultants, CMOs, and regulatory vendors, contributing to scalable processes and governance.
Requirements
- Advanced degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline (PhD preferred; MS or equivalent with significant relevant experience considered).
- 10+ years of Regulatory Affairs experience with deep understanding of global CMC regulatory requirements across the full product lifecycle.
- Demonstrated experience supporting both investigational and commercial products, including small molecule and antisense oligonucleotide (ASO) therapeutics.
- Proven track record of authoring and/or overseeing CMC sections of INDs and NDAs, as well as post-approval supplements.
- Direct experience interacting with FDA and other global regulatory authorities on CMC-related matters.
- Experience in biotech or pharmaceutical development; CNS, rare disease, or precision medicine experience is a plus.
- Prior people management and/or matrix leadership experience preferred.
- Strong strategic and operational leadership skills, with the ability to balance investigational and commercial priorities.
- Excellent written and verbal communication skills.
- Ability to work effectively in a fast-paced, cross-functional environment.
Benefits
- 99% of the premium paid for medical, dental and vision plans.
- Company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage.
- 401(k) matching dollar-for-dollar up to 6% on eligible contributions.
- Long-term stock incentives and ESPP.
- Discretionary quarterly bonus.
- Extremely flexible wellness benefit.
- Generous PTO, paid holidays and company-wide shutdowns.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Regulatory CMC strategiesINDsIMPDsNDAspost-approval supplementsprocess validationcontrol strategiesstability programscomparability assessmentstechnology transfers
Soft Skills
strategic guidancecross-functional partnershipleadershipcommunicationoperational leadershippeople managementmatrix leadershipability to balance prioritiesability to work in fast-paced environmentoversight
Certifications
PhDMS in ChemistryMS in Pharmaceutical SciencesMS in Chemical Engineering