Job Description

Overview Join to apply for the Regulatory Affairs Associate III role at Katalyst CRO . Location: Broomfield, CO. Salary range: $65,600.00-$82,000.00. Posted 2 days ago. Responsibilities Under general supervision responsible for the coordination and the preparation of documents/packages for regulatory submissions. Review and evaluate technical and scientific data and reports required for submission in support of company products. Track status and progress of regulatory documentation. Review, edit and proofread regulatory documentation. Assist in preparation and review of labeling, SOPs, and other departmental documents. Compile under supervision regulatory documents for submission. Participate as an active team member of project teams as required. Compile and prepare responses to regulatory authorities questions. Maintain regulatory files in a format consistent with requirements. Maintain awareness of regulatory requirements. May be responsible for a specific product portfolio in the region. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Qualifications Bachelor's degree or country equivalent in pharmacy or related scientific discipline with 0-2 years regulatory experience, preferably within a healthcare environment. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Scientific knowledge; written and verbal communication skills. Systems skills (e.g., word processing, spreadsheets, databases, online research); proofreading and editing skills. Ability to contribute to multiple projects from a regulatory affairs perspective. Ability to multitask and prioritize. Seniority level Entry level Employment type Full-time Job function Legal #J-18808-Ljbffr Katalyst CRO

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