Global CMC Regulatory Strategy Lead

OpenKrill; United States; Remote; USD 177,000 - 221,000; Full time

Job summary

Revolution Medicines seeks an Associate Director, CMC Regulatory to lead global CMC regulatory strategies supporting clinical development, regulatory submissions, and lifecycle management of the company’s oncology portfolio. You will chair cross‑functional teams, prepare CMC sections for IND/NDA/MAA submissions, and ensure compliance with GMP requirements worldwide.

The role requires strong experience in CMC regulatory affairs, excellent communication, and the ability to drive timelines in a

Qualifications

• BA/BS in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field.
• 10+ years of pharmaceutical/biotech drug development experience with 5+ years in global CMC regulatory affairs.
• Experience in CMC global submissions (IND, IMPD/CTA, NDA, MAA, etc.) (US, EU, APAC, LATAM).
• Knowledge of US and international GMP quality regulations.
• Experience with CMC development of NCEs (small molecules).
• Ability to prioritize multiple projects in a dynamic, global environment.

Responsibilities

• Develop, lead and implement global CMC regulatory strategies to support clinical development, registration, and post‑marketing activities.
• Lead the preparation and maintenance of CMC/quality sections for regulatory submissions (IND, IMPD/CTA, NDA, MAA, etc.).
• Serve as the CMC regulatory representative on project teams and support development and lifecycle management of products.
• Collaborate with regulatory teams, CMC SMEs and CROs to identify regional CMC requirements and drive submission timelines.
• Provide regulatory assessment and guidance on CMC changes, deviations and investigations.
• Contribute to internal process improvements and SOP development to support globalization of RevMed’s products.

Skills

Communication skills

Cross-functional collaboration

Project management

Regulatory strategy

Regulatory submissions

Education

BA/BS in Pharmaceutical Science or related field

Advanced degree (MSc/PhD) desirable

Job description

Revolution Medicines seeks an Associate Director, CMC Regulatory to lead global CMC regulatory strategies supporting clinical development, regulatory submissions, and lifecycle management of the company’s oncology portfolio. You will chair cross‑functional teams, prepare CMC sections for IND/NDA/MAA submissions, and ensure compliance with GMP requirements worldwide.

The role requires strong experience in CMC regulatory affairs, excellent communication, and the ability to drive timelines in a