Sr. Associate, Regulatory Operations
Alcon · Panama
Descripcion del puesto
About the role
Alcon is seeking a Sr. Associate in Regulatory Operations to support its Quality & Regulatory Affairs function. You will work on compliance activities such as Change Control, Audit Management, and Quality Metrics while ensuring regulatory documents meet audit schedules and regulations.
Key responsibilities
- Perform specialized tasks and independent research to optimize outcomes for medical device and pharmaceutical products.
- Prepare dossiers for new registrations, changes, renewals, and promotional material submissions.
- Maintain up‑to‑date databases of submissions and approvals.
- Make decisions within the scope of assigned tasks to achieve project goals.
- Apply advanced analytical skills and self‑direction while adhering to GxP regulations.
- Follow Standard Operating Procedures, maintain accurate documentation, ensure quality control, and complete required training.
- Contribute to overall organizational compliance and continuous improvement.
Required profile
- Bachelor’s degree or equivalent experience.
- Minimum 2 years of relevant regulatory or quality experience.
- Fluent reading, writing, and communication skills in English.
Required skills
- Regulatory dossier preparation for medical devices and pharmaceuticals.
- GxP compliance and SOP adherence.
- Change control and audit management.
- Database maintenance of submissions and approvals.
- Analytical and self‑directed work style.
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Publicado hace 1 mes
Expira en 3 semanas
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Alcon
Panama
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