Regulatory Affairs Specialist
hace 2 semanas
Regulatory Affairs Coordinator - Job Summary
Galderma Pharma S.A seeks a skilled Regulatory Affairs Coordinator to implement regulatory programs, processes, and policies to support regulatory activities related to product regulatory, drugs CMC regulatory, regulatory operations, and scientific medical writing.
Key Responsibilities:
- Implement Regulatory Affairs programs and policies for preparation, submission, and follow-up of medical affairs and authorities (MAA) and archive registration files.
- Assist in writing and editing manuscripts on clinical studies and/or scientific reports including special summaries from raw data for submission to regulatory agencies or for in-company use.
- Track product safety and fulfill the regulatory requirements compliant with legislation and regulations pertaining to the business.
- Implement Regulatory Affairs plans and processes for all activities related to Regulatory reporting/documentation for internal and external audiences.
Requirements:
- Master's / Bachelor's Degree or equivalent experience/qualification.
- Minimum 4 years of experience in Regulatory Affairs, ideally in Peru, Ecuador, Bolivia, Venezuela, Cono Sur.
- Experience in the pharmaceutical, cosmetic, and/or medical device industry.
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