
Business-Focused Regulatory Compliance Specialist
Há 4 dias
We are seeking a skilled Regulatory Affairs Specialist to execute registration strategies and ensure regulatory compliance.
Key Responsibilities:- In partnership with the RA team, develop and execute registration strategies for designated regional projects related to new/existing products, according to local regulation, approved licenses, and company alignment.
- Adhere to environmental policy and procedures and support departmental objectives.
- Work closely with leadership to ensure rapid and timely approval of new and existing products.
- Assist with ensuring compliance with regulatory agency regulations and interpretations.
- Prepare responses to regulatory agencies questions and other correspondence.
- Conduct searches of existing files for requested information.
- Manage payments/PO in the SAP system related to the Regulatory area.
- Support updating databases and requesting documents/deliverables.
- Partner with other functions to define and obtain regulatory deliverables.
- Bachelor's degree in health-related courses with a minimum of 1 year of Regulatory experience in a regulated industry (could include pharmaceutical, medical device, or associated consumer industries).
- Fluent in Portuguese and advanced in English (written and verbal).
- Intermediate Spanish level as a plus.
- Result-oriented, initiative, proactive.
- Team player.
- Good communication skills, open-minded.
- Demonstrated ability to handle multiple projects.
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