Associate Director, CMC Regulatory

revolutionmedicines; United States; On-site; USD 180,000 - 280,000; Full time

Job summary

Revolution Medicines seeks an Associate Director, CMC Regulatory to lead global regulatory strategies for clinical development and lifecycle management of RAS(ON) candidates. You will coordinate CMC sections for INDs, IMPDs, NDAs and MAAs, ensuring timely submissions and regulatory alignment across US, EU, APAC and LATAM.

Collaborating with CMC SMEs, CROs and project teams, you’ll drive regulatory excellence, risk assessment and lifecycle changes while guiding cross-functional teams in a

Qualifications

• BA/BS in Pharmaceutical Science, Chemistry, Chemical Engineering or closely related field.
• 10+ years in pharmaceutical/biotech drug development with 5+ years in global CMC regulatory affairs.
• Experience with global CMC submissions (IND, IMPD/CTA, NDA, MAA) across US, EU, APAC, LATAM.
• Solid knowledge of GMP quality regulations and regulatory considerations for development and marketed products.

Responsibilities

• Develop, lead, and implement global CMC regulatory strategies for clinical development and post-marketing activities.
• Lead preparation and maintenance of CMC sections for regulatory submissions (IND, IMPD/CTA, NDA, MAA).
• Serve as CMC regulatory representative on project teams and ensure regulatory requirements are met.
• Collaborate with regulatory teams, SMEs and CROs to meet submission timelines and regional requirements.
• Provide regulatory assessments on CMC changes, deviations, investigations throughout product life cycle.

Skills

Regulatory strategy

Global collaboration

Regulatory submissions

Cross-functional coordination

Education

BA/BS in Pharmaceutical Science

Chemistry or Chemical Engineering

Advanced degree desirable

Tools

IND submissions

IMPD/CTA submissions

NDA/MAA submissions

Job description

Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.

Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor-all in service of patients.

The Opportunity:

As part of our expanding organization, we seek a strategic and hands-on Associate Director, CMC Regulatory who will be responsible for executing CMC regulatory strategies to support clinical development, marketing authorizations, and lifecycle management of RevMed's pipeline compounds/products. This role involves coordinating and preparing CMC sections of regulatory submissions to support RevMed's global clinical trials, market applications and post approval changes. The ideal candidate should have a strong understanding of global regulatory requirements during different phases of development, and be able to provide regulatory guidance to the CMC teams accordingly.

Responsibilities:

• Develop, lead, and implement global CMC regulatory strategies to support the clinical development, registration, and post-marketing activities.
• Lead the preparation and maintenance of the CMC / quality sections for regulatory submissions including initial submission of IND, IMPD/CTA, NDA, MAA and amendments to Health Authorities (HAs), and preparation of responses to queries from HAs.
• Serve as the CMC regulatory representative on project teams and provide CMC regulatory support for the development of the investigational product(s) and marketed products and ensure applicable regulatory requirements are appropriately met.
• Collaborate with corporate regulatory team, CMC SMEs and/or CROs to identify regional/country-specific CMC requirements to support global applications, and to drive the CMC submission timelines in order to meet business objectives.
• Provide regulatory assessment and guidance on CMC related change controls, deviations, and investigations throughout product life cycle.
• Lead and/or contribute to internal process improvements, SOP development, and organizational initiatives to support globalization of RevMed's products. Maintain knowledge of global competitive landscape, regulatory environment, regulations and CMC guidance, providing interpretation to internal stakeholders.

Required Skills, Experience, and Education:

• BA/BS degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field.
• 10+ years of pharmaceutical / biotech drug development experience with 5 + years of experience of global CMC regulatory affairs.
• Experience in CMC related global submissions (IND, IMPD/CTA, NDA, MAA, etc.) (US, EU, APAC, LATAM).
• Solid knowledge of US and international GMP quality regulations, current industry practices, and experience with interpretation and application to development projects and marketed product regulatory issues.
• Working experience and content knowledge in CMC development of NCEs (small molecules) or equivalent.
• Demonstrated experience in effective collaboration with internal and external stakeholders.
• Ability to prioritize and manage multiple projects simultaneously in a dynamic company environment.
• Ability to operate effectively in a fast-paced, matrixed, global environment.
• Effective written and verbal communication skills and excellent interpersonal skills.

Preferred Skills:

• Advanced degree (MSc or PhD degree) in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field is desirable.
• Experience in accelerated development program.
• Self-driven, proactive, and able to operate independently while fostering collaboration across departments.

#LI-CT1 #LI-Remote

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and developmen