REMOTE Director of Regulatory Affairs

Company: Meet
Location: Lakeland
Posted on: February 16, 2020

Job Description:

One of--Meet's--top clients is a global, successful CRO who partners with leading pharmaceutical, biotech, and medical device companies across the globe.--They are looking to hire a Director of Regulatory Affairs & Compliance to head up both departments for the business.-- This role is FULLY REMOTE for candidates based in either MI, OH, PA, NC, SC, or FL. Responsibilities: Provide strategic input and technical guidance on regulatory requirements to project teams including oversight for the publishing of regulatory submissions according to ICH guidance. Responsible for working with internal and external teams, as well as vendors, to manage short- and long-term global regulatory activities that support the success of investigational and marketed pharmaceutical products throughout their lifecycle. Observe and adhere to applicable regulatory and legal requirements, including participation in impact assessments for clients for any regulatory updates. Develop and maintain SOPs, work practices, forms and other documentation and training materials related to regulatory and compliance services. Job Requirements: Graduate degree in scientific, medical, clinical discipline or related field, or related experience. At least 7 years of Regulatory and Compliance experience. Thorough understanding of regulatory guidance and practices pertaining to submissions and approval processes. Demonstrable experience of stakeholder/ relationship management with a client focused approach to work. Familiarity with 21 CFR Part 11, FDA, and GCP requirements. Contact Details:---- Full job description and company details are available upon application. This position is being dealt with by Kasey Dillon at Meet, email directly at kasey@peoplewithchemistry.com to discuss further and in confidence.

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