job description
At Tatawa Industries (M) Sdn Bhd, we are redefining the role of a Regulatory Affairs Specialist. This isnât just about maintaining recordsâitâs about transforming compliance into a strategic asset that drives business success. If you thrive in a dynamic environment where precision meets innovation, this is your opportunity to make a tangible impact.
As our Regulatory Affairs Specialist, you will be the guardian of our adherence to local and international regulations, ensuring our manufacturing, transport, and logistics operations meet the highest standards. Your expertise will not only mitigate risks but also position us as a leader in regulatory excellence within the industry.
Join us in Bali, where professional growth meets an inspiring work-life balance. Whether you're based in Canggu, Ubud, or Denpasar, youâll be part of a team that values meticulousness, proactivity, and a forward-thinking approach to compliance.
Responsibility
- Monitor and interpret evolving local, national, and international regulations affecting manufacturing, transport, and logistics operations.
- Develop, implement, and maintain compliance strategies to ensure adherence to industry standards and legal requirements.
- Prepare and submit regulatory documentation, permits, and reports to relevant authorities in a timely and accurate manner.
- Collaborate with cross-functional teams (e.g., Quality Assurance, Legal, Operations) to align processes with regulatory expectations.
- Conduct internal audits and risk assessments to identify gaps and recommend corrective actions.
- Serve as the primary liaison with regulatory bodies, responding to inquiries and facilitating inspections.
- Provide training and guidance to staff on regulatory requirements and best practices.
- Stay ahead of industry trends and regulatory changes to proactively adjust company policies and procedures.
Qualifications
- Bachelorâs degree in Pharmacy, Chemistry, Law, Business Administration, or a related field. Advanced degrees or certifications (e.g., RAC) are a plus.
- Minimum 3-5 years of experience in regulatory affairs, preferably within manufacturing, transport, or logistics sectors.
- In-depth knowledge of Indonesian and international regulatory frameworks (e.g., FDA, ISO, GMP, customs regulations).
- Proven ability to interpret complex regulations and translate them into actionable business processes.
- Exceptional attention to detail, organizational skills, and the ability to manage multiple deadlines.
- Strong communication and negotiation skills, with fluency in English (written and verbal).
- Proficiency in regulatory software/tools and Microsoft Office Suite.
- Analytical mindset with problem-solving capabilities to address compliance challenges.