Description of Work: Latin America Quality Regulatory Affairs Specialist Essential Duties and Responsibilities:
- Responsible for the coordination and support of Latin America product registration requests throughout the product lifecycle
- Support regional and country colleagues to develop and implement global regulatory strategies
- Coordinates and collects specific registration information with R&D, Manufacturing, QA, Medical and other applicable departments, as necessary to support registration requirements
- Collaborate with regional regulatory personnel on assessing and documenting the reginal impact of product changes on global product registrations and licenses.
- Knowledgeable in Latin American regulations and is able to interpret and communicate regulatory changes to ensure the business is aware of opportunities, risks and issues
- Demonstrates collaboration with their regulatory team, cross functional team members, and regulatory agency partners by building strong and effective working relationships
- Responsible for coordinating the submission of Technovigilance reports in the region
Sthree US is acting as an Employment Business in relation to this vacancy.