Job Description

Job Description

• Regulatory Affairs is responsible for planning, coordinating and implementing regulatory strategies for products that require government approval in SEA and Korea.
• Demonstrates working knowledge of healthcare-related regulations.
• Demonstrates in-depth knowledge of preparing a submission.
• Demonstrates in-depth knowledge of industry and competitive products.
• Applies relevant regulations and statutes to further product submissions of basic to medium complexity.
• Contributes to the strategic direction of regulatory pathway development.
• Refines and conforms the preliminary data used in the submission process.
• Translates technical data and descriptions into reviewer-friendly content.
• Helps to ensure that the appropriate regulatory requirements for the submission are met. Interacts with regulatory body and internal stakeholders to help further product approvals or clearance.
• Review and approve product labeling/advertising for compliance to country-specific regulations
• Has in-depth experience, knowledge and skills in own job family.
• Applies knowledge and skills to a wide range of standard and non-standard situations.
• Maintain accurate records of submissions, approvals, and correspondence in compliance with company procedures and global standards.
• Works independently with minimal guidance. Usually determines own work priorities
• Acts as a resource for colleagues with less experience
• Perform additional responsibilities as assigned.

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