Reg Submission Coordinator (Veeva RIM & MS Projects)
syneoshealth · ARG-Remote
Descripcion del puesto
About the role
The Reg Submission Coordinator supports the preparation and submission of regulatory applications, ensuring compliance with government regulations and meeting tight timelines.
Key responsibilities
- Prepare and submit full IND, marketing and lifecycle maintenance applications.
- Conduct quality control reviews of documents and track submissions to final delivery.
- Maintain regulatory databases, records, and logs according to company and client requirements.
- Identify project risks, propose resolutions, and escalate issues when needed.
- Assist in training and mentoring team members on project requirements.
Required profile
- Experience handling non‑complex regulatory submissions independently.
- Ability to work under supervision for complex submissions and meet cost and time estimates.
- Strong attention to detail and ability to process information with high reliability.
Required skills
- Veeva RIM
- MS Projects
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Publicado hace 1 semana
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syneoshealth
ARG-Remote
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