Regulatory Management & Trade Compliance Pharmacist

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

The Regulatory Management and Trade Compliance Pharmacist will oversee regulatory compliance and trade operations for life sciences products. In addition, they will serve as the accountable pharmacist for PBF raw materials, ensuring compliance with pharmaceutical regulations and quality standards. The position involves managing regulatory submissions, ensuring adherence to trade compliance standards, and supervising the distribution of pharmaceutical products.

Regulatory Management

• Ensure compliance with local, national, and international regulations related to pharmaceutical and Food products, including registration, import license application, and import license approval.
• Prepare, submit, and manage regulatory documentation for product registrations, product import licenses, renewals, and amendments.
• Monitor and interpret regulatory changes and provide guidance to the company on their impact.

Trade Compliance

• Manage import and export compliance for life sciences products, including customs documentation and HS code classification.
• Ensure adherence to trade regulations and international trade agreements.
• Resolve issues related to customs and trade compliance and support the audits.

Pharmaceutical Wholesale Distribution (PBF) Oversight

• Act as the responsible pharmacist for pharmaceutical wholesale distribution, ensuring adherence to Good Distribution Practice (GDP) and other regulatory requirements.
• Supervise and manage the distribution of pharmaceutical products, ensuring compliance with all relevant regulations.
• Maintain accurate records of distribution activities and oversee the handling and storage of pharmaceutical products.

Documentation and Reporting 

• Maintain accurate records of regulatory submissions, trade compliance activities, and pharmaceutical transactions.
• Prepare reports and documentation for internal and external stakeholders, including regulatory agencies.
• Develop and update standard operating procedures (SOPs) to enhance compliance and operational efficiency.
• Identify and implement improvements in regulatory and trade compliance processes

Coordination and Communication

• Collaborate with internal teams, such as the quality team, ISCO, CE, and commercial departments, to ensure regulatory and trade compliance.
• Develop and deliver training on regulatory and trade compliance requirements to staff.
• Serve as the point of contact for regulatory authorities and trade compliance agencies.

Quality Assurance

• Oversee the quality assurance of pharmaceutical products and raw materials, ensuring compliance with Good Distribution Practice (GDP) and other relevant standards.
• Support internal audits and inspections to ensure adherence to quality standards.

WHO YOU ARE

• Bachelor’s degree in pharmacy or a related field; master’s degree or higher preferred.
• Licensed pharmacist with active registration.
• Minimum of 5 years of experience in regulatory management, trade compliance, Accountable Pharmacist, or related fields in the life sciences industry.
• In-depth knowledge of pharmaceutical regulations, trade compliance, and customs procedures.
• Expertise in pharmaceutical wholesale distribution and adherence to GDP requirements.
• Excellent analytical, organizational, and communication skills.
• Ability to work independently and manage multiple tasks in a fast-paced environment.
• Fluent in Bahasa and native & English (verbal and written)
• Certification in Regulatory Affairs or Trade Compliance is a plus
• Experience in managing PBF raw materials and pharmaceutical products is a plus

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it 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 our diverse team!