Join our dynamic team where innovation and care converge in a culture that values continuous learning, diversity and transformative career development. Underpinned by THRIVE with Zuellig Pharma, our commitment to transforming the way we grow, care and succeed together as one organization, we are dedicated to helping our people make a meaningful impact in healthcare.
Compliance Specialist
Jakarta Pusat, Indonesia, 10410
About Us:
PT Anugerah Pharmindo Lestari (APL) a Zuellig Pharma company, is a leading healthcare solution in Indonesia, and our purpose is to make healthcare more accessible to the communities we serve.
We provide world-class distribution, commercialization, and clinical trial support to support the growing healthcare needs in this region. The company was started forty years ago and has grown to become a billion-dollar business covering 514 cities with over 2,500 employees.
Our people serve more than 60,000 direct and indirect medical facilities and work with over 50 clients, including the top 20 pharmaceutical companies in the world.
Purpose of the Role:
Responsible to execute and monitoring technical activities which relate to product registration as to meet company objectives and any reporting to HA in compliance to country regulations.
What You’ll do:
- Prepare and submit report of actual use drug product under Special Access Scheme to BPOM applied when there is importation of drug product under Special Access Scheme.
- Prepare artworks for applications and or for commercials use and maintain its current version
- Collaborate with Regulatory Manager and Principal to generate submission plan upon request
- Ensure registration dossier are well prepared and submitted as planned
- Monitoring on review process and take actions to ensure timely product approval
- Keep updated with new regulations and changes within regulatory bodies to ensure compliance with local regulations or policies
What Will Make You Successful:
Must Have:
- Bachelor’s degree
- Good understanding of pharmaceutical compliance is preferable
- Proficiency in writing and oral communication skills in English and Bahasa.
- Willing to be placed in Jakarta
Advantages to Have:
- Minimum 1 years' experience in Pharmaceutical compliance.
Why join APL:
- We are committed to fostering an inclusive environment where our employees can learn, grow, and achieve shared success.
- We champion diversity, equity, and inclusion, ensuring every individual feels valued, respected, and treated fairly.
- As a leading multi-market healthcare solutions provider, we empower our employees to gain comprehensive knowledge and expertise in the dynamic healthcare industry across the region.
- Enjoy the flexibility to effectively balance your work and personal life while taking charge of your career journey through our empowering growth opportunities.
- Our Total Rewards program is designed to support your overall well-being in every aspect.
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