AI Success™

Job Description

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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 in 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.

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

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

â¢ 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.

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

â¢ 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.

â¢ 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.

â¢ 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. ï¼ååç´ 760ï¼

ï¿½ï¿½ Who You Areï¼6â8 é è¦æ±ï¼å«æè½ãç¶é©ãå¸æ·ãè¡çºæºåï¼

â¢ 8+ year experience in Trade Compliance or Regulatory Management, team leading or project leading experience is preferred
â¢ Knowledge of customs regulations, licensing requirements, and commodity classification.
â¢ Strong analytical and problemâsolving skills with high attention to detail.
â¢ Excellent English communication skills, both written and verbal.
â¢ Digitalâsavvy and comfortable working with systems and data.
â¢ Bachelorâs degree in Life Science, Chemistry, Regulatory Affairs, or related field is a plus.
â¢ Demonstrates Merck values: integrity, accountability, collaboration, and commitment to compliant and ethical business conduct.
â¢ Highly engaged, ownershipâdriven, and able to work independently while supporting crossâfunctional teams.

About Merck Group

This channel is not intended for U.S. and Canadian visitors. Merck operates in the U.S. and Canada as EMD Serono in Healthcare, MilliporeSigma in Life Science and EMD Electronics in Electronics. An unaffiliated and unrelated company, Merck & Co., Inc., Kenilworth, NJ, US holds the rights in the trademark MERCK in the U.S. and Canada.

_______________________________

We are Merck, a leading global science and technology company headquartered in Germany.

We are curious explorers, courageous pioneers, and ingenious inventors. Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Life Science, Healthcare, and Electronics.

Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and the planet.

We believe in the positive power of science and technology. It has determined our actions since 1668 and inspires us to continue researching for a future worth living. As a family-owned company with over 350 years of experience, we stand for sustainability, responsibility, and innovative strength.

We take pride in being a diverse and inclusive company that values and fosters the talents and abilities of our employees. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

Work your Magic and join Merck.

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Data Privacy Declaration: www.merckgroup.com/en/privacy-statement

Industry

Chemicals & Materials

Company Size

10,000+ employees

Headquarters

Darmstadt, DE

Year Founded

Unknown

Website

merckgroup.com

Social Media

Regulatory and Trade Compliance Manager

Job Description

About Merck Group