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Senior Regulatory Management & Trade Compliance Specialist
Senior Regulatory Management & Trade Compliance SpecialistMerck Life Science • Petaling Jaya, Selangor, Malaysia
Senior Regulatory Management & Trade Compliance Specialist

Senior Regulatory Management & Trade Compliance Specialist

Merck Life Science • Petaling Jaya, Selangor, Malaysia
30+ hari lalu
Penerangan pekerjaan

Senior Regulatory Management & Trade Compliance Specialist

Join to apply for the Senior Regulatory Management & Trade Compliance Specialist role at Merck Life Science

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That''s why we are always looking for curious minds that see themselves imagining the unimaginable with us.

What You Do

  • This position is responsible for leading and managing regulatory and trade compliance activities in Malaysia. 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, MOH, DOSH, MOFA, DVS, MDA, MAQIS, 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.

Strategy

What You Do

  • 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 Malaysia.

    • Main Roles – Operational Excellence

  • Effectively manage regulatory pathway for company Life Science (LS) products and services in Malaysia. Secure 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 (MY 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 Malaysia.
  • 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

  • Degree of pharmacy and must be a Registered Pharmacist and willing and legible to be designated as the company''s Poison License holder.
  • Job Knowledge : Have at least 8-years regulatory and trade compliance experience in multi-national life science relevant industries.
  • Hard Skills : Extensive knowledge of chemical and life science law in Malaysia including Poison act, dangerous drugs act, psychotropic regulation, medical device regulation, animal act, explosive, pesticide, chemical weapon convention act, and experienced in obtaining import license for Life Science related products.
  • Soft Skills : 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.
  • Computer literate : Excellent knowledge of Windows 365 and standard Microsoft office modules. Familiar with Power automate and Power BI are preferable.

    • What we offer

    We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

    Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

    #J-18808-Ljbffr

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