Job Description
Job Overview
We are searching for a Regulatory Affairs Analyst to help improve patient care and collaborate across the industry to make healthcare more affordable and accessible. The role supports regulatory submissions and drives compliance across all company areas. A flexible working arrangement is available with presence in our office in São Paulo, Brazil.
Responsibilities
- Direct or perform coordination and preparation of document packages for regulatory submissions from all areas of the company, internal audits, and inspections.
- Lead or compile all materials required in submissions, license renewals, and annual registrations.
- Recommend changes for labeling, manufacturing, marketing, and clinical protocols for regulatory compliance.
- Monitor and improve tracking/control systems.
- Keep abreast of regulatory procedures and changes.
- Direct interaction with regulatory agencies on defined matters.
- Rec...