Job Details
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.