job description
Join Sinocare Healthcare Indonesia as a Regulatory Affairs Specialist and play a pivotal role in ensuring compliance, product registrations, and regulatory approvals in the dynamic healthcare industry. Based in beautiful Bali, you will collaborate with government agencies, manage licensing processes, and contribute to the growth of a leading healthcare company committed to innovation and quality.
This is an exceptional opportunity for a detail-oriented professional with a passion for regulatory affairs to thrive in a supportive and fast-paced environment. If you are eager to make a meaningful impact in healthcare compliance, we invite you to apply and become part of our mission to deliver excellence in medical solutions.
Responsibility
- Manage and oversee the registration and licensing of healthcare products in compliance with Indonesian regulatory requirements.
- Coordinate with government agencies, including the Ministry of Health and BPOM, to ensure timely approvals and renewals.
- Prepare, review, and submit regulatory documentation, including dossiers, labels, and technical files.
- Monitor and interpret changes in healthcare regulations to ensure company compliance and proactive adjustments.
- Collaborate with cross-functional teams, including R&D, legal, and marketing, to align regulatory strategies with business objectives.
- Conduct internal audits and risk assessments to identify and mitigate compliance gaps.
- Serve as the primary liaison for regulatory inspections, audits, and inquiries.
- Maintain accurate records and databases of regulatory submissions, approvals, and correspondence.
Qualifications
- Bachelor’s degree in Pharmacy, Life Sciences, or a related field. Advanced degrees or certifications in Regulatory Affairs are a plus.
- Minimum of 3 years of experience in regulatory affairs within the healthcare, pharmaceutical, or medical device industry.
- In-depth knowledge of Indonesian healthcare regulations, including BPOM and Ministry of Health requirements.
- Strong analytical, organizational, and problem-solving skills with keen attention to detail.
- Excellent written and verbal communication skills in both English and Bahasa Indonesia.
- Proven ability to manage multiple projects and meet tight deadlines in a fast-paced environment.
- Proficiency in Microsoft Office Suite and regulatory database management systems.
- High ethical standards and a commitment to maintaining confidentiality and compliance.