Revolution Medicines

Revolution Medicines

Associate Director, CMC Regulatory

Remote (United States) · Director · Full-time

Sponsorship not specified$177k-$221kDetected 5 hours ago
ComplianceClinical TrialsGMPCommunicationCollaboration

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odds of building a lasting career here

61Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70

Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.

Lottery odds assume a STEM candidate.

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Employer immigration record

from this employer's Department of Labor filings

Files H-1B transfers

9 transfer filings in the last year, covering 9 workers. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.

Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.

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About the role

  • 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.
  • 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.
  • 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.
  • Ability to prioritize and manage multiple projects simultaneously in a dynamic company environment.

Requirements

  • 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.

Skills

  • 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).
  • 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 operate effectively in a fast-paced, matrixed, global environment.
  • Effective written and verbal communication skills and excellent interpersonal 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.

Compensation

  • $177,000 - $221,000 USD
  • Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process.

Benefits

  • Required Skills, Experience, and Education:

Company info

  • 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.
  • Base Pay Salary Range $177,000 - $221,000 USD We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines.
  • Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process.
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This listing is sourced directly from Revolution Medicines's careers page and normalized into a canonical job model.