job description
Join PT. PASSPORTINDO ASIA GLOBAL as a Regulatory Affairs (RA) Officer/Specialist and play a pivotal role in ensuring regulatory compliance and supporting product legality in the dynamic healthcare and medical industry. Based in the vibrant regions of Bali, this position offers a unique opportunity to work in a fast-paced environment while contributing to the company's mission of delivering high-quality, compliant products to the market.
As a Regulatory Affairs Specialist, you will be responsible for navigating complex regulatory landscapes, liaising with government agencies, and ensuring that all products meet local and international standards. This role is ideal for detail-oriented professionals with a strong background in regulatory affairs, legal compliance, and the healthcare sector.
If you are passionate about regulatory compliance, have a keen eye for detail, and thrive in a collaborative environment, we invite you to apply and become a key player in our regulatory team.
Responsibility
- Ensure compliance with local and international regulatory requirements for healthcare and medical products.
- Prepare, review, and submit regulatory documentation to government agencies and regulatory bodies.
- Monitor and interpret changes in regulations and guidelines to ensure ongoing compliance.
- Collaborate with cross-functional teams, including R&D, legal, and quality assurance, to align product development with regulatory standards.
- Act as the primary liaison between the company and regulatory authorities during audits, inspections, and product registrations.
- Develop and implement regulatory strategies to expedite product approvals and market entry.
- Maintain accurate and up-to-date records of regulatory submissions, approvals, and correspondence.
- Provide training and guidance to internal teams on regulatory requirements and best practices.
Qualifications
- Bachelor's degree in Pharmacy, Life Sciences, Law, or a related field. A Master's degree is a plus.
- Minimum of 3 years of experience in regulatory affairs, preferably in the healthcare, pharmaceutical, or medical device industry.
- In-depth knowledge of Indonesian regulatory requirements and familiarity with international regulations (e.g., FDA, EMA, ASEAN).
- Strong analytical and problem-solving skills with the ability to interpret complex regulatory documents.
- 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.
- Detail-oriented with a high level of accuracy in documentation and reporting.
- Proficiency in Microsoft Office Suite and regulatory database management systems.