- 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).
- 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.
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Regulatory Affairs Specialist - Durham, United States - PSI CRO
Description
Company DescriptionPSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
Job Description
Join our team of experts in regulatory and ethics submissions of clinical studies You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career.
This is a hybrid role which includes remote and in-office work.
Your role:
Qualifications
If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.
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