job description
Join Primover Consultancy Services, Inc. as a Regulatory Operations Coordinator and play a pivotal role in supporting our Regional Regulatory Hub in the dynamic Healthcare & Medical sector. Based in the vibrant region of Badung, Bali, this position offers a unique opportunity to contribute to critical administrative and operational functions that drive regulatory compliance and efficiency across our organization.
In this role, you will collaborate closely with the Regulatory Affairs Manager and cross-functional teams to ensure seamless operations, adherence to industry standards, and timely submission of regulatory documentation. Your organizational skills, attention to detail, and ability to navigate complex regulatory landscapes will be key to our success in maintaining compliance and supporting business growth.
If you are a proactive professional with a passion for healthcare regulations, operational excellence, and a desire to work in a fast-paced, international environment, we invite you to apply and become part of our mission to deliver high-quality regulatory solutions.
Responsibility
- Coordinate and manage administrative tasks for the Regional Regulatory Hub, ensuring efficient workflow and documentation processes.
- Assist in the preparation, review, and submission of regulatory filings, applications, and reports to local and international authorities.
- Maintain and update regulatory databases and tracking systems to ensure accuracy and compliance with deadlines.
- Liaise with internal stakeholders (e.g., Legal, Quality Assurance, R&D) to gather necessary information for regulatory submissions.
- Monitor and track changes in healthcare regulations and industry guidelines, communicating updates to relevant teams.
- Support the Regulatory Affairs Manager in coordinating meetings, preparing agendas, and documenting action items.
- Ensure all regulatory documentation is organized, version-controlled, and readily accessible for audits or inspections.
- Provide operational support for product registrations, licensing, and compliance-related activities.
Qualifications
- Bachelor’s degree in Pharmacy, Life Sciences, Business Administration, or a related field.
- Minimum of 2-3 years of experience in regulatory affairs, operations, or administrative support within the healthcare, pharmaceutical, or medical device industry.
- Strong understanding of regulatory processes and compliance requirements (e.g., FDA, EMA, or local health authorities).
- Excellent organizational, communication, and project management skills.
- Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint) and regulatory management software.
- Ability to work independently, prioritize tasks, and meet tight deadlines in a fast-paced environment.
- Familiarity with document control systems and electronic submission platforms (e.g., eCTD) is a plus.
- Fluency in English; additional language skills are advantageous.