job description
Join a dynamic healthcare organization as a Regulatory Affairs and Technical Executive in the vibrant heart of Bali. This pivotal role ensures compliance with global and local healthcare regulations while maintaining the highest quality standards. You will serve as the bridge between technical teams and regulatory bodies, ensuring seamless product approvals and market access.
Based in Canggu, Bali, this position offers a unique opportunity to work in a tropical paradise while contributing to impactful healthcare solutions. The ideal candidate will have a sharp eye for detail, a deep understanding of regulatory frameworks, and a passion for maintaining compliance in a fast-paced industry.
If you thrive in a role that combines technical expertise with strategic regulatory oversight, this is your chance to make a difference in a growing sector.
Responsibility
- Develop, review, and submit regulatory documentation to local and international authorities to ensure timely product approvals.
- Monitor and interpret changes in healthcare regulations, advising internal teams on compliance requirements.
- Conduct technical assessments of products, processes, and documentation to ensure adherence to quality and safety standards.
- Collaborate with cross-functional teams (R&D, Quality Assurance, Manufacturing) to align product development with regulatory expectations.
- Prepare and maintain regulatory dossiers, including labeling, packaging, and promotional material compliance.
- Represent the company in interactions with regulatory agencies, addressing inquiries and resolving compliance issues.
- Implement and maintain a robust regulatory intelligence system to track emerging trends and updates.
- Provide training and guidance to internal stakeholders on regulatory policies and best practices.
Qualifications
- Bachelor’s degree in Pharmacy, Life Sciences, Biochemistry, or a related field. Advanced degrees (MSc, PhD) are a plus.
- Minimum 3-5 years of experience in regulatory affairs within the healthcare, pharmaceutical, or medical device industry.
- In-depth knowledge of local (Indonesian) and international regulatory frameworks (e.g., FDA, EMA, ASEAN guidelines).
- Proven track record of successful regulatory submissions and approvals for medical products.
- Strong analytical and problem-solving skills with meticulous attention to detail.
- Excellent written and verbal communication skills in English; proficiency in Indonesian is advantageous.
- Ability to work independently and manage multiple priorities in a deadline-driven environment.
- Familiarity with GMP, ISO, and ICH guidelines is highly desirable.