1. Regulatory Strategy & Market Access,
Develop and execute regulatory strategies for:
Injectable aesthetic products.
Medical devices for home use (energy-based, beauty devices, skincare devices).
Advise management on regulatory pathways, timelines, and risks.
Support business decisions related to new product introduction, portfolio expansion, and international expansion.
2. Product Registration & Lifecycle Management,
Lead preparation, submission, renewal, variation, and maintenance of:
Drug / injectable product registrations.
Medical device registrations (including classification & conformity assessment).
Manage full product lifecycle from pre-launch to post-market changes.
Act as regulatory owner for assigned product portfolios.
3. Regulatory Intelligence & Risk Management.
Monitor and interpret regulatory laws, notifications, and guidelines related to:
Aesthetic injectables.
Medical devices (especially home-use devices).
Proactively assess regulatory risks and propose mitigation plans.
Communicate regulatory impact clearly to commercial and management teams.
4. Labeling, Claims & Promotional Review.
Review and approve:
Product labeling, IFU, packaging.
Marketing and promotional materials (on-label / off-label risk control).
Provide clear regulatory guidance to Marketing and Sales to enable compliant promotion.
Ensure alignment with Thai FDA and applicable international standards.
5. Cross-functional & External Coordination.
Work closely with:
Marketing, Medical Affairs, Sales, Supply Chain, Quality.
Coordinate with:
Manufacturers, suppliers, overseas principals, consultants.
Represent the company in communications with regulatory authorities (e.g. Thai FDA).
6. Audit, Inspection & Compliance Support.
Support and lead regulatory activities during:
FDA inspections.
Internal audits.
Supplier or principal audits.
Ensure proper documentation, readiness, and corrective actions.
7. Regulatory Leadership & Expertise.
Act as Regulatory Specialist / Advisor, not administrative RA.
Mentor junior RA team members (if applicable).
Drive continuous improvement of regulatory processes and standards.
