Regulatory Affairs Officer
Conduct regulatory assessments and documentation, develop compliance procedures, and assist in inspections; requires strong communication and collaboration skills in regulatory.
Skills
About This Role
Overview
- Conduct thorough assessments of regulatory requirements for new products, ensuring compliance with local and international standards.
- Prepare and submit regulatory documentation, including dossiers and variations, to health authorities in a timely and accurate manner.
- Develop and implement internal regulatory procedures and training programs to maintain compliance throughout the organization.
- Conduct risk assessments to identify regulatory hurdles and propose effective solutions to mitigate potential issues.
- Assist in the preparation for regulatory inspections and audits, ensuring all documentation and processes are in order.
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