Regulatory & Trade Compliance (Contract)

Merck Life Science; Indonesia; On-site; IDR 180,000,000 - 260,000,000; Full time

Job summary

Merck Life Science is seeking a Regulatory Affairs specialist to evaluate and fulfill regulatory requirements for pharmaceutical raw materials and R&D chemicals, and to review importation and distribution documentation.

You will maintain regulatory databases, monitor changes, prepare correspondence with authorities, support import licensing, review HS codes, coordinate with EXIM, and leverage SAP and AI tools to streamline processes.

Qualifications

• Bachelor’s degree in life sciences is required.
• Minimum 2 years of experience in Regulatory Affairs or Trade Compliance.
• Experience with regulatory documentation for imports and distribution.

Responsibilities

• Regulatory Affairs: evaluate and fulfill regulatory requirements for pharmaceutical raw materials and R&D chemicals.
• Review regulatory documentation for importation and distribution of products.
• Maintain accurate regulatory databases and licensing documents.
• Monitor regulatory changes from government authorities and prepare correspondence.
• Trade Compliance: support import licensing and review HS codes and product status.
• Coordinate with EXIM to ensure compliant import processes.

Skills

Regulatory Affairs

Trade Compliance

Import Compliance

Power BI

Power Automate

AI tools

Microsoft 365

Excel

Education

Bachelor’s degree (S1) in Chemistry, Chemical Engineering, Biology, Biotechnology, or related Life Science

Tools

SAP

Job description

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.

About The Role

• Regulatory Affairs
• Support the evaluation and fulfillment of regulatory requirements for pharmaceutical raw materials and R&D chemicals.
• Review regulatory documentation required for the importation and distribution of products.
• Maintain accurate and up-to-date regulatory databases and licensing documentation.
• Monitor regulatory changes and updates issued by relevant government authorities.
• Prepare regulatory documents, letters, and correspondence with regulatory authorities and relevant stakeholders.
• Trade Compliance
• Support import licensing and trade compliance processes.
• Review import requirements, HS Codes, and product regulatory status.
• Coordinate with the EXIM team to ensure smooth and compliant import processes.
• Utilize and navigate SAP for relevant regulatory and trade compliance processes.
• Digitalization & AI
• Identify opportunities to digitalize and streamline Regulatory & Trade Compliance processes.
• Develop and maintain dashboards, databases, and document repositories using Microsoft 365.
• Utilize Microsoft Copilot, AI tools, Power Automate

Who You Are

• Bachelor’s degree (S1) in Chemistry, Chemical Engineering, Biology, Biotechnology, or other related Life Science disciplines.
• Minimum 2 years of experience in Regulatory Affairs, Trade Compliance, Import Compliance, or the Life Science/Pharmaceutical industry.
• Experience handling the importation of pharmaceutical raw materials or laboratory chemicals is a strong advantage.
• Good understanding of import and trade regulations related to pharmaceutical raw materials and chemicals.
• Familiarity with technical documentation such as SDS/MSDS, CoA, and Technical Data Sheets.
• Proficient in Microsoft 365 applications, including Excel, PowerPoint, Word, Teams, and SharePoint.
• Understanding of Power BI, Power Automate, Microsoft Copilot, and AI tools to improve workplace productivity.
• Strong attention to detail, good communication skills, and ability to work effectively with cross-functional teams.

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!