Director - CMC Regulatory

1w1 week ago

Revolution Medicines

Basel, CH · Full-time · CHF 220,000 – CHF 320,000

About this role

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The R&D pipeline includes RAS(ON) inhibitors like daraxonrasib (RMC-6236), elironrasib (RMC-6291), zoldonrasib (RMC-9805), and RMC-5127 in clinical development. Join outstanding professionals committed to patients with RAS pathway mutations.

As part of the expanding European organization, serve as a strategic and hands-on Director, CMC Regulatory, Europe. Develop and execute regional CMC regulatory strategies for early development, marketing authorizations, and lifecycle management across Europe. Ensure successful interactions with EMA, NCAs, and other regulatory bodies.

Lead early- and late-stage CMC regulatory activities, including clinical trial applications, MAAs, post-approval variations, and lifecycle strategy. Provide deep expertise in EU regulatory frameworks with strong cross-functional collaboration. Proactively identify and manage regulatory risks while supporting business objectives.

Partner with global Regulatory Affairs, Quality, Technical Operations, and external partners for compliant submissions. Represent CMC regulatory on cross-functional teams, aligning global strategy with regional execution. Contribute to building regional CMC regulatory expertise through leadership and mentorship.

Requirements

Deep expertise in EU regulatory frameworks
Strong cross-functional collaboration skills
Ability to proactively identify and manage regulatory risks
Experience ensuring successful interactions with EMA and NCAs
Proven leadership in early- and late-stage CMC regulatory activities
Knowledge of clinical trial applications, MAAs, post-approval variations, and lifecycle strategy
Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related scientific discipline
Advanced degree (PhD, PharmD, MSc) desirable

Responsibilities

Provide CMC regulatory support for clinical trial applications and regulatory interactions, ensuring alignment with EU requirements and timelines
Develop and lead execution of European CMC regulatory strategies to support initial marketing authorizations and lifecycle management
Oversee preparation, review, and submission of high-quality CMC dossiers for EU MAAs, variations, renewals, and line extensions
Serve as the primary CMC regulatory lead for Europe, managing interactions with EMA, NCAs, and other European regulatory bodies
Provide strategic input into global regulatory strategies, ensuring alignment while addressing EU-specific requirements
Assess regulatory impact of CMC changes and provide proactive, risk-based guidance to ensure compliance with EU regulations
Interpret and apply EU regulatory requirements (EMA, ICH, EU GMP, and national guidance) to support efficient pathways
Partner with global teams and external vendors to ensure timely, high-quality regulatory submissions and approvals