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Associate Director / Director – CMC Dossier

Revolution Medicines

Redwood City, CA, US
  • Job Type: Full-Time
  • Function: Manufacturing
  • Industry: Biotechnology
  • Post Date: 09/20/2022
  • Website: www.revmed.com
  • Company Address: 700 Saginaw Drive, Redwood City, CA, 94063

About Revolution Medicines

REVOLUTION Medicines discovers and develops new drugs that harness the therapeutic potential of frontier oncology targets on behalf of cancer patients. Our innovative product engine draws inspiration from nature and evolution, which offer insights into cancer targets, disease mechanisms and therapeutic approaches.

Job Description

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit high-value frontier targets in RAS-addicted cancers.  The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

Playing a critical role within CMC function, as CMC Dossier Lead, the position will coordinate submission activities with cross-functional CMC, Quality and corporate Regulatory Operations teams in support of Revolution Medicines pipeline compound development and clinical programs.

The Opportunity:

  • Be responsible for preparing and maintaining CMC / Quality sections for global regulatory submissions.

  • Collaborate with CMC subject matter experts (SMEs) and functional lead(s) on the regulatory preparation and submission strategies, and responses to health authorities’ inquiries / questions.

  • Author and/or review the submission content for CMC / Quality sections as appropriate.

  • Create and maintain CMC dossier preparation and submission timelines in order to meet the corporate regulatory submission goals.

  • Keep up to date on regulatory trends and requirements and/or national law and communicate timely and effectively within CMC department.

Required Experience, Skills and Education:

  • Preferably a graduate degree (MS, PhD) in chemistry, pharmaceutical science or related discipline.

  • 6+ years of CMC regulatory experience in pharmaceutical industry with NCE small molecules and oncology development experience.

  • Experience in preparing/managing CMC regulatory submissions (IND and IMPD are required; NDA / MAA is a plus).

  • In depth understanding of CMC content and / or working experience in CMC related space such as drug substance, drug product and / or analytical development and manufacturing.

  • Solid knowledge of US regulations / guidelines and extensive experience with ICH, European regulations and guidelines.

  • Excellent scientific and business communication skills (verbal and written), strong organizational and planning skills.

  • Strong interpersonal/collaboration skills with demonstrated ability to effectively work with cross-function teams such as Process R&D, Pharmaceutical Development, QA, Supply Chain, Analytical Development, CMC Operation PM and Regulatory Operations.

  • Ability to think critically and be able to work independently.

  • Ability to multi-task and thrive in a fast-paced innovative environment.

Revolution Medicines currently requires that all personnel and visitors to its offices be fully vaccinated against COVID-19. This role will require that the employee meet with company employees and work from the company’s offices. Given that these essential functions of the role must be performed on-site, this position requires full COVID-19 vaccination, subject to applicable law.

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition and veteran status.

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