Regulatory Compliance Executive - #1106294

Regulatory Liaison & Licensing
Lead the coordination and submission of licensing applications to the Health Sciences Authority (HSA) for TCM and CPM products.
Maintain up-to-date knowledge of HSA regulations, guidelines, and industry standards.
Respond to inquiries and provide required documentation for regulatory approvals.
Ensure timely renewal of licenses and registration for products in line with regulations.

Good Manufacturing Practices (GMP) Compliance
Develop, implement, and enforce GMP guidelines for all stages of TCM and CPM product production, including repacking, pulverizing, and tablet/capsule manufacturing.
Regularly audit production processes to ensure compliance with GMP and HSA regulations.
Provide training and guidance to operational teams on GMP standards and practices.
Oversee corrective actions for any non-conformance issues related to GMP.

Product Safety & Quality Assurance
Monitor and ensure the safety and quality of all TCM and CPM products in compliance with relevant regulations.
Collaborate with the operation team to conduct internal audits, tests, and inspections.
Ensure the proper implementation of safety and quality control measures throughout the production process.
Manage product testing, including ensuring lab tests for microbial, chemical, and heavy metal content meet regulatory standards.

Labeling and Packaging Compliance
Ensure that all product labeling complies with HSA regulations, including ingredient declarations, claims, dosage instructions, and any necessary warnings.
Liaise with the marketing and design teams to ensure compliance with regulatory guidelines for packaging.
Monitor any changes in labeling laws and apply necessary updates.

Product Listing & Regulatory Approvals
Oversee the product listing process with HSA and other relevant regulatory bodies.
Ensure all products are listed and classified correctly according to regulatory standards.
Track and maintain accurate records of all product listings and approvals.

Export Compliance
Ensure compliance with the regulatory requirements for exporting products to various countries.
Liaise with regulatory bodies to confirm that products meet their specific market requirements.
Provide regulatory guidance to the logistics and distribution teams for smooth international trade operations.

Continuous Improvement & Reporting
Stay informed of industry trends and regulatory updates, ensuring the company remains compliant with evolving standards.
Prepare regular compliance reports and present them to senior management.
Implement continuous improvements to operational efficiency and compliance measures.


Job Requirements:

 Bachelor's degree in Pharmacy, Life Sciences, or a related field (preferably with experience in TCM or CPM).

At least 5 years of experience in regulatory affairs, compliance, or quality management within the TCM/CPM industry, with a focus on GMP.

Strong knowledge of Singapore's HSA regulatory requirements for TCM and CPM products.

Experience in obtaining licenses and product registrations for healthcare products in Singapore and abroad.

Ability to interpret complex regulations and guidelines, and communicate them effectively to internal teams.

Strong attention to detail and ability to manage multiple tasks efficiently.

Excellent communication and interpersonal skills.