Job Description

• Responsible for the coordination and preparation of document packages for regulatory submissions from all areas of the Company.
• Keeps abreast of regulatory procedures and changes.
• Coordinates the collection of documents, records, reports, and data from the Development, Clinical Affairs, Quality, and Operations Departments for inclusion in regulatory documents.
• ssists in the preparation of international registration dossiers for use in international registration by affiliates.
• Participates with internal/external teams and builds professional relationships.
• Identifies and suggests solutions to Regulatory tasks.

• Bachelor's Degree or equivalent
• 5 years of related Regulatory Affairs experience.
• bility to travel based on business needs.

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