Regulatory Affairs Specialist
2 weeks ago
Immediate need for Regulatory Affairs Specialist with a Clinical Research Organization in Raleigh.Hybrid position - will work partly in office and partly remote.Looking for a Regulatory Affairs Specialist with at least 2 years of regulatory experience along with submissions. Will work on IND submissions (publishing and structure of the IND, not the strategic side).Responsible for liaising with project teams to procure documents necessary for regulatory and ethics committee submissions.Responsible for the preparation of regulatory and ethics committee submission dossiers, including applications for import and export licenses, where applicable.Responsible for reviewing translations of essential documents subject to regulatory or ethics committee submissions, if regionally applicable (shared with project teams).Primary responsibility for tracking regulatory project documentation flow and progress reporting.Supervised responsibility for maintaining a database of regulatory requirements.Primary or secondary responsibility for registration/marketing authorization projects and renewals (where applicable).Responsible for the compilation and review of Investigational New Drug Applications (INDs).Primary or secondary contact person for ethics committees and regulatory authorities, project teams on all regulatory-related issues, and co-contractors, subcontractors, and third- party vendors (regulatory issues).Secondary responsibility for the development and update, if necessary, of project planning documents, including project timelines (regulatory aspects) and safety management plan, where applicable (in cooperation with Medical Affairs).Responsible for review of investigational product release-enabling documents.Primary or secondary responsibility for training company employees inregulatory practices.Responsible for ensuring accurate and time-bound reporting ofsafety issues to authorities and reviewing incoming safety reports for completeness.Provide assistance to business development at client presentations, bid defense meetings, and the like in various regulatory aspects (at the discretion of Senior Regulatory Affairs staff).QualificationsMust have a College/University degree or an equivalent combination of education, training and experience.Must have 3+ years of hands-on relevant Regulatory Affairs experience.Experience with the review, maintenance, and compilation of the IND lifecycle and submissions.Experience interacting with and acting as the liaison with the FDA/Sponsor/ etc.Prior experience with Health Canada is a plus.Proficiency in MS Office applications.Detail-oriented, ability to learn, plan and work in a dynamic team environment.Must have excellent communication, collaboration, and problem-solving skills.#J-18808-Ljbffr
by Jobble
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Raleigh, United States GlaxoSmithKline Full timeSite Name: USA - North Carolina - Research Triangle Park, Bangalore, India - Maharashtra - Mumbai, Poznan Grunwaldzka, UK - London - Brentford Posted Date: Apr 30 2024 Are you interested in a highly visible, global role that allows you to lead a team of regulatory experts while being part of the CMC regulatory leadership team to contribute to the advancement...
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