job description
Join Getz Healthcare as a Regulatory Affairs Officer and play a pivotal role in ensuring compliance with local and international healthcare regulations. In this dynamic position, you will guide product submissions, collaborate with cross-functional teams, and uphold the highest standards of safety and quality for our life-changing medical products.
Based in the vibrant and culturally rich environment of Bali, you will contribute to delivering innovative healthcare solutions while navigating the complex landscape of regulatory requirements. Your expertise will be instrumental in maintaining our commitment to excellence and patient safety.
If you are a detail-oriented professional with a passion for regulatory compliance and a desire to make a tangible impact in the healthcare industry, we invite you to apply and become part of our mission-driven team.
Responsibility
- Prepare, review, and submit regulatory documentation to health authorities in compliance with local and international regulations.
- Monitor and interpret changes in healthcare laws, guidelines, and standards to ensure ongoing compliance.
- Collaborate with R&D, Quality Assurance, and Manufacturing teams to align product development with regulatory requirements.
- Coordinate and manage product registrations, renewals, and variations for pharmaceuticals, medical devices, or healthcare products.
- Liaise with regulatory agencies, responding to inquiries and facilitating inspections or audits.
- Develop and implement regulatory strategies to expedite product approvals and market access.
- Maintain accurate and up-to-date regulatory records, databases, and documentation.
- Provide regulatory training and guidance to internal stakeholders to foster a culture of compliance.
Qualifications
- Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, or a related field. Advanced degrees (e.g., Master’s in Regulatory Affairs) are a plus.
- Minimum of 3-5 years of experience in regulatory affairs within the healthcare, pharmaceutical, or medical device industry.
- In-depth knowledge of Indonesian regulatory requirements (e.g., BPOM) and familiarity with international standards (e.g., FDA, EMA, ICH).
- Proven track record of successful product registrations, submissions, and compliance audits.
- Strong analytical, problem-solving, and project management skills with attention to detail.
- Excellent written and verbal communication skills in English; proficiency in Indonesian is advantageous.
- Ability to work independently and collaboratively in a fast-paced, multicultural environment.
- Proficiency in regulatory software and Microsoft Office Suite.