Regulatory Affairs Specialist
About this role
Regulatory Affairs Specialist
Sao Paulo, SP, Brazil
On-site
Job Description Carrying out, controlling and implementing activities related to the company's quality system. Carrying out, controlling and implementing the regulatory processes applicable to the company's activities and products. Providing support to the LATAM RAQA manager in the department's activities.
Responsibilities
Essential Functions & Accountabilities:
- Prepare and review dossiers for product notification/registration, renewals and/or changes;
- Active involvement with new projects and new product developments.
- Proper evaluation of technical documents, change controls, dossiers, gap assessments, etc.
- Identify trends, assess impact, analyze alternatives and recommend action plans
- If necessary, acts as Technical Responsible Person in front of Brazilian authorities
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