[Hiring] Director, CMC Regulatory @Revolution Medicines

Role Description

The Director, CMC Regulatory (post-approval) is responsible for providing strategic, hands-on and operational leadership for global post-approval submissions and CMC activities for Rasonque and other commercial products in RevMed’s portfolio. This role will lead complex global CMC lifecycle regulatory strategies across products and manufacturing sites, enabling timely execution of post-approval regulatory activities while improving submission efficiency, and simplifying regulatory processes. The individual will also support the successful transition of commercial-stage programs to the CMC-RA post-approval function. When required, the individual will also support development programs working with CMC-RA colleagues to accomplish the required regulatory deliverables and submissions.

This is accomplished with a strong working knowledge of global regulations, guidelines, and regulatory precedence, coupled with a strong technical knowledge of development, technology transfers and manufacturing processes.

Responsibilities

• Serve as regulatory lead on assigned commercial programs/projects.
• Develop and implement post-approval regulatory strategies for assigned products defining filing approaches and data expectations for site changes, analytical updates, specification changes, site additions, and related lifecycle activities.
• Provide high-quality, timely, and decisive regulatory advice to allow project teams to make well-informed decisions on product lifecycle planning; anticipate and resolve technical or operational issues that could impact submission timelines.
• Lead preparation, review, and execution of supplements, variations, annual reports, renewals, and related submissions.
• Perform regulatory assessments for change controls and deviations for assigned products by applying risk-based principles to categorize and prioritize post-approval changes.
• Collaborate with cross-functional stakeholders and peers within PDM, RA, Quality, Commercial, and other functions including local in-country colleagues, to define and execute endorsed global regulatory strategies and accomplish high-quality, and timely post-approval submissions.
• Monitor emerging regulatory guidance related to lifecycle management and apply it strategically to current and future submissions; identify opportunities to simplify lifecycle processes or accelerate submissions.
• Support development programs when required to accomplish CMC-RA deliverables and submissions.
• Provide guidance and mentorship to junior CMC-RA colleagues and contribute to improving CMC regulatory processes and submission standards.

Qualifications

• Bachelor’s degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related scientific discipline.
• Minimum of 15 years of experience in pharmaceutical/biotech drug development, including 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, current industry practices, with a demonstrated ability to interpret and apply requirements for commercial products.
• Strong project and team leadership capabilities, with the ability to prioritize effectively, manage multiple complex programs, and foster cross-functional collaboration.
• Effective written and verbal communication skills and interpersonal skills.
• A collaborative, high-energy team player who thrives in a fast-paced, dynamic environment and embraces innovation and continuous improvement.

Preferred Skills

• Advanced degree (MS or Ph.D) in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field.
• Experience with other modalities regulated by CDER, e.g., antibody therapeutics, ADCs, etc.

Benefits

• Competitive cash compensation.
• Robust equity awards.
• Strong benefits.
• Significant learning and development opportunities.

Base Pay Salary Range

$201,000 — $251,000 USD