job description
Join a dynamic team in Bali as a QA Regulatory Affairs Specialist, where you will play a pivotal role in ensuring compliance with local and international regulatory standards. This position is ideal for detail-oriented professionals passionate about maintaining the highest quality and safety standards in manufacturing, transport, and logistics.
In this role, you will prepare, review, and submit regulatory dossiers, registrations, renewals, and variations to relevant authorities, ensuring timely approvals and adherence to evolving regulations. Your expertise will directly contribute to the seamless operation of our regulatory processes, supporting business growth and market access.
Based in the vibrant and culturally rich regions of Bali, this opportunity offers a unique work-life balance in one of the worldâs most sought-after destinations. Whether you're in Canggu, Ubud, or Denpasar, youâll thrive in an environment that values innovation, precision, and collaboration.
Responsibility
- Prepare, review, and submit regulatory dossiers, applications, and documentation to local and international authorities.
- Ensure compliance with current and emerging regulatory requirements in manufacturing, transport, and logistics.
- Manage registrations, renewals, and variations for products, maintaining accurate and up-to-date records.
- Liaise with regulatory agencies, internal teams, and external stakeholders to facilitate smooth approval processes.
- Monitor regulatory changes and assess their impact on business operations, providing strategic recommendations.
- Conduct gap analyses and implement corrective actions to address compliance deficiencies.
- Collaborate with cross-functional teams to align regulatory strategies with business objectives.
- Maintain a comprehensive knowledge base of regulatory guidelines and industry best practices.
Qualifications
- Bachelorâs degree in Pharmacy, Life Sciences, Chemistry, or a related field. Advanced degrees are a plus.
- Minimum of 3 years of experience in regulatory affairs, quality assurance, or a similar role within manufacturing, transport, or logistics.
- In-depth knowledge of local (Indonesian) and international regulatory frameworks (e.g., FDA, EMA, ICH).
- Proven experience in preparing and submitting regulatory documentation, including dossiers and variations.
- Strong analytical, problem-solving, and project management skills.
- Excellent written and verbal communication skills in English.
- Ability to work independently and collaboratively in a fast-paced environment.
- Familiarity with regulatory software and databases is an advantage.