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Job Description
- Coordinate, prepare or review regulatory submissions for international projects.
- Maintain current Knowledgebase of existing and emerging regulations, standards, or guidance documents.
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
- Review product, labeling, batch records, specifications sheet, or test methods for compliance with applicable regulations and policies.
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
- Direct the collection of samples as requested by regulatory agencies.
Job Requirements
- BSc of pharmaceutical sciences
- 1-3 years of experience in regulatory affairs.
- Broad knowledge of pharmaceutical science.
- Excellent Computer skills.
- Very good command of the English language, read, written and spoken.
- Having good organizational and communication skills.
