Director, CMC Regulatory
About The Position
The Director, CMC Regulatory (post-approval) provides strategic, hands-on, and operational leadership for global post-approval submissions and CMC activities for Rasonque and other commercial products in Revolution Medicines’ portfolio. The role leads complex global CMC lifecycle regulatory strategies across products and manufacturing sites, enabling timely post-approval regulatory activity, improving submission efficiency, and simplifying regulatory processes. The Director also supports the transition of commercial-stage programs to the CMC-RA post-approval function and, when needed, supports development programs and their regulatory deliverables and submissions. The position requires strong knowledge of global regulations, guidelines, and regulatory precedent, along with technical knowledge of development, technology transfers, and manufacturing processes.
Requirements
- Bachelor’s degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or a closely related scientific discipline.
- At least 15 years of experience in pharmaceutical or biotech drug development.
- At least 5 years of hands-on global CMC regulatory affairs experience supporting post-approval lifecycle management of small molecule products, particularly solid oral dosage forms.
- Strong knowledge of US and international regulations and current industry practices, with the ability to interpret and apply requirements for commercial products.
- Strong project and team leadership capabilities, including prioritizing effectively, managing multiple complex programs, and fostering cross-functional collaboration.
- Effective written and verbal communication and interpersonal skills.
- Collaborative, high-energy team player who thrives in a fast-paced, dynamic environment and embraces innovation and continuous improvement.
Nice To Haves
- Advanced degree (MS or Ph.D.) in Pharmaceutical Science, Chemistry, Chemical Engineering, or a closely related field.
- Experience with other modalities regulated by CDER, such as antibody therapeutics or ADCs.
Responsibilities
- Serve as regulatory lead on assigned commercial programs and projects.
- Develop and implement post-approval regulatory strategies, defining filing approaches and data expectations for site changes, analytical updates, specification changes, site additions, and related lifecycle activities.
- Provide timely, decisive regulatory advice to inform product lifecycle planning and anticipate and resolve technical or operational issues that could affect submission timelines.
- Lead the preparation, review, and execution of supplements, variations, annual reports, renewals, and related submissions.
- Perform regulatory assessments of change controls and deviations, applying risk-based principles to categorize and prioritize post-approval changes.
- Collaborate with cross-functional stakeholders and colleagues in PDM, RA, Quality, Commercial, and other functions, including local in-country colleagues, to define and execute global regulatory strategies and deliver high-quality, timely submissions.
- Monitor emerging regulatory guidance related to lifecycle management and apply it to current and future submissions.
- Identify opportunities to simplify lifecycle processes or accelerate submissions.
- Support development programs as needed to complete CMC-RA deliverables and submissions.
- Guide and mentor junior CMC-RA colleagues and contribute to improvements in CMC regulatory processes and submission standards.
Benefits
- Competitive cash compensation.
- Robust equity awards.
- Strong benefits.
- Significant learning and development opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Director
