Regulatory Affairs Specialist

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 in
• regulatory practices.
• Responsible for ensuring accurate and time-bound reporting of
• safety 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).

Qualifications

• Must 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.