Regulatory and Trade Compliance Manager

與我們攜手施展你的超能力！  

準備好接受挑戰，探索更多可能性嗎? 我們跟你一樣希望精益求精，持續突破! 我們全球的夥伴熱衷於科技創新，透過我們醫藥保健、生命科學和電子科技業務的解決方案豐富人們的生活。讓我們一起環抱著熱情和夢想關懷我們的員工、客戶、病患和這個世界。這就是我們不斷尋找具備好奇心的新血加入的原因，與我們一起大膽想像各種可能。

This position will manage regulatory affairs and trade compliance for Merck Life Science (LS) business in Taiwan with effective management and strategy development. Drive, manage and coordinate regulatory and trade compliance projects in Taiwan, including managing thought leadership initiatives, product registrations, license/permit application, authorities communication, supporting business needs, customer training/requests. Lead Regulatory Management and Trade Compliance Taiwan team. Facilitate and maintain excellent working relationship with government officials and customers.

Regulatory Management:

• Effective manage regulatory pathway for Merck Life Science (LS) products and services in Taiwan, cover the areas of APIs, pharmaceutical excipients, medical devices, IVDs, equipment/instrument, biologics and animal derived materials.
• Drive, manage and coordinate registration / notification / listing activities i. n Taiwan. Ensure the correctness and timeliness of these activities, interim follow-up change management and final outcome. Ensure tracking, maintenance and reporting of registration / notification / listing status.
• Monitor changes within relevant regulatory and compliance environment, influence and shape future guidance, regulations and policy. Provide regulatory guidance in risk assessment, identify regulatory impact to Merck LS and provide regulatory recommendations to mitigate potential risk.
• Increase focus on building and strengthening relationship with Taiwan regulatory authorities to mitigate compliance risks and safe guard Merck LS interest. Build and maintain excellent relationship with Taiwan regulatory authorities with effective written and verbal communication.
• Take active role to represent company in delicate or risk potential matters with Taiwan regulatory agencies, inspectors and trade associations.
• Provide regulatory support to marketing, sales and customers via consultation, seminars and training events.

Trade Compliance:

• Develop and update trade compliance SOP for Taiwan legal entities lead or collaborate with internal functions for smooth and compliant operation.

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

•       Coordinate self-assessments and periodic audits in LS Taiwan organization.

•       Conduct 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.

•       Manage the efficiency of daily customs affairs agreed with KPIs and business requirement.

•       Interface with customs authorities, freight forwarders and customs brokers to process import and export shipments. Trade compliance audits of external service providers. Monitor and report on changes of relevant trade compliance environment with impact with the Life Science business.

•       Make full use of Merck GTS (global trade service) system, integrate import/export and domestic trading requirements into the order screening process, to ensure transactional compliance.

•       Identify opportunities for process efficiency and effectiveness in compliance through automation or process improvement, put in place compliance-related metrics and a program for continuous improvement. （字元約 760）

📌 Who You Are（6–8 項要求，含技能、經驗、學歷、行為準則）

• 8+ year experience in Trade Compliance or Regulatory Management, team leading or project leading experience is preferred
• Knowledge of customs regulations, licensing requirements, and commodity classification.
• Strong analytical and problem‑solving skills with high attention to detail.
• Excellent English communication skills, both written and verbal.
• Digital‑savvy and comfortable working with systems and data.
• Bachelor’s degree in Life Science, Chemistry, Regulatory Affairs, or related field is a plus.
• Demonstrates Merck values: integrity, accountability, collaboration, and commitment to compliant and ethical business conduct.
• Highly engaged, ownership‑driven, and able to work independently while supporting cross‑functional teams.

我們來自不同背景、視角與生活經歷，因對世界的好奇心而聚集在一起。我們深信，多元能夠催生卓越與創新，並持續強化我們在科學與技術領域的領導地位。我們致力於為每一個人創造機會，讓大家能依自己的節奏發展與成長。加入我們，一同打造一個充滿包容與歸屬感的文化，影響數百萬人的生活，攜手推動人類的進步！

立即申請，成為這個致力於激發探索精神、提升人類未來的團隊一員！