Regulatory Management and Trade Compliance Manager

Your Roles:

This position is responsible for leading and managing regulatory and trade compliance activities in Vietnam. Key responsibilities include engaging with authorities for communication and advocacy, supporting business needs, optimizing the business model, and responding to customer training and requests. The role also involves building and maintaining strong relationships with government agencies (e.g., Customs, MOIT, DOIT, etc.), industry associations, NGOs, and internal stakeholders such as Quality, Customer Service, Sales & Marketing, Warehouse, and Logistics teams.

The objective is to ensure seamless execution of business operations from a regulatory and trade compliance perspective, while maintaining full adherence to local laws and guidelines relevant to Life Science (LS) business activities.

This is a full-time position based in Vietnam.

This position reports to Head of Regulatory Management & Trade Compliance, SEA.

What You Should Do:

Strategy:

Take initiatives for building up relationship and advocacy with local authorities and trade associations in terms of Life Science interests. Safeguard company strategic interests and objectives in arising regulations.

Manage and support businesses on evolving requirements in a rapidly changing legal landscape.

Drive and develop digitalization strategy and automation tools to improve efficiency and improve data quality.

Develop and update trade compliance SOP for legal entity and define and clarify the roles & responsibilities of Trade Compliance and other internal functions for smooth collaboration.

Drive implementation of policies and instructions through monitoring, make proper communication on regulation change and implication analysis.

Coordinate self-assessments and reporting on LS Regulatory & trade compliance status in Vietnam.

Operational Excellence:

Effectively manage regulatory pathway for company life science products and services in Vietnam. S ecure and ensure timely application for license registration, renewal registration and recommendation letter issues, with good coordination with Supply and Distribution team.

Provide guidance in risk assessment, identify compliance impact to Life Science and provide recommendations to mitigate potential risk. Take active role to represent company in delicate or risk potential matters with authorities, inspectors and trade associations.

Regularly check the LS shipment by land, air and sea freight whether the items require import license/permit/authorizations, prepare and submit the necessary application and getting the license//permit/authorizations ready before shipment arrival (for the license/permit/authorizations which need to be attached with the shipment documents)

Drive, manage, and coordinate registration/ notification/ listing activities. Ensure the correctness and timeliness of these activities, interim follow-up change management and final outcome. Ensure tracking, maintenance, renewal, declaration, and reporting of registration/ notification/ listing status.

Obtain any regulation updates from authorities. Monitor relevant new/update relevant regulatory, make risk assessment, identify the possible impact, and communicate clearly to stakeholders.

Interface with customs authorities, freight forwarders and customs brokers to process import and export shipments. Support Customs clearance for imported goods (VN HS code and Goods description assignment, other legal issues relating to trade compliance)

Determine local Commodity HS codes and types of license/permits needed in Vietnam.

Identify, implement, adhere and update internal regulatory procedures and process improvement for smoother process flow e.g., creation of Standard Operating Procedures in accordance with Quality Assurance; to update any changes where applicable.

Attend to customer enquiries on regulatory matters and conduct safety / regulatory talks to customer, whenever required.

Review, classify and maintain import/export and domestic trading requirements into the relevant ERP system, to ensure transactional compliance.

Where applicable, provide regulatory training/briefing to current/new colleagues of the division.

To perform other ad-hoc duties assigned from time to time.

Who You Are:

Bachelor's Degree in life science area (e.g. Chemistry, Science or Microbiology, Biotechnology,  Pharmacy, related science), law, or international trade.

At least 8-years trade compliance experience in multi-national life science relevant industries.

Extensive knowledge of chemical law in Vietnam including hazardous chemical control law, Chemical Weapon Control, Chemical inventory, industrial precursor, and experienced in obtaining import license for Life Science related products.

Good communication with impact, excellent negotiation and presentation skills, proactive handling of regulatory change, results-oriented, resilient, teamwork and collaboration.

Active member in relevant association industry and have great connection with relevant authority is highly preferable.

Excellent knowledge of Windows 365 and standard Microsoft office modules. Familiar with Power automate and Power BI are preferable.

Fluent in spoken and written English and Vietnamese.