The Regulatory Compliance Specialist performs the role of a regulatory site officer within the quality organization. Routine regulatory activities include change assessment, dossier development for post-marketing changes, ensuring product and site renewals are completed on time, responding to health authority questions, and maintaining dossier compliance.
Bachelor's Degree in Engineering or Science with 3 or more years of experience in the pharmaceutical industry. Minimum 2 years of regulatory CMC experience required. Employee must be familiar with industry expectations for dossier writing and information expected to be provided for post-market changes.
Job Type: Contract
Salary: From $40.00 per hour
Benefits:
Schedule:
Supplemental pay types:
Ability to commute/relocate:
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Work Location: One location
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