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Mason Alert:

George Mason University in-person classes are cancelled and administrative offices are closed Monday Jan 26, due to inclement weather. For more information about campus operations go here: https://www.gmu.edu/campus-status.

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George Mason University
Job Opportunity

Associate Director, CMC Regulatory at Vanda Pharmaceuticals Inc.

Full Job Details

Employer: Vanda Pharmaceuticals Inc.

Expires: 03/19/2026

The Associate Director, CMC Regulatory Specialist will be responsible for preparing and reviewing CMC documentation for drug substance and drug product, ensuring compliance with FDA, EMA, and ICH guidelines, and supporting regulatory trategies for submissions and post-approval changes. The role also includes collaborating with internal and external experts, managing regulatory assessments, and addressing gaps in data from contract manufacturing organizations.Job Responsibilities:Review drug substance and drug product information for completeness and up to current regulatory standardsPrepare CMC sections for drug substance and drug product information/dataReview relevant FDA/EMA/ICH guidelines to ensure completenessPrepare responses to FDA/EMA questionsDevelop regulatory strategy for original submission and post approval variationsPerform regulatory assessment on CMC change controlsParticipate in drug substance and drug product development activities to ensure appropriate data for INDs/NDAs/IMPDs/MAAs are generatedWork with contract manufacturing companies to address any gaps in information/dataCollaborate with drug substance, drug product and analytical chemistry subject matter experts to prepare CMC sectionsJob RequirementsMS or PhD degree in pharmaceutical sciences or medicinal chemistry~8 to 10 years pharmaceutical R&D experience with at least 3 to 5 years of regulatory CMC experienceThorough knowledge and understanding of biologics and sterile productsGood writing skillsMust be able to perform the essential functions of the position, with or without reasonable accommodation; however, reasonable accommodations will be provided for qualified individuals with disabilities unless doing so would impose undue hardship.The total compensation package for this position will also include incentive compensation and benefits such as health insurance, unlimited paid time off, parental leave, a 401k matching program, and other benefits to its employees.We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, gender identity, sexual orientation, protected veteran status, or any other characteristic protected by law.If you reside in a state or locality with enacted pay transparency laws, you are entitled to request and receive additional details regarding compensation and benefits. For assistance, please contact us at 202-524-8238 between 8:00 AM and 5:30 PM ET, Monday through Friday.

* The programs and services offered by George Mason University are open to all who seek them. George Mason does not discriminate on the basis of race, color, religion, ethnic national origin (including shared ancestry and/or ethnic characteristics), sex, disability, military status (including veteran status), sexual orientation, gender identity, gender expression, age, marital status, pregnancy status, genetic information, or any other characteristic protected by law. After an initial review of its policies and practices, the university affirms its commitment to meet all federal mandates as articulated in federal law, as well as recent executive orders and federal agency directives.