job description
Are you passionate about ensuring products meet regulatory standards while driving innovation? Join our dynamic team as a Product Development, Importation & Regulatory Affairs Officer in Bali. This role is pivotal in bridging product innovation with legal compliance, ensuring seamless market entry and consumer safety.
Based in the vibrant regions of Canggu, Ubud, Denpasar, Jimbaran, Nusa Dua, Kuta, or Badung, you will collaborate with cross-functional teams to navigate regulatory landscapes, streamline importation processes, and support product development initiatives. Your expertise will be instrumental in maintaining compliance with local and international regulations while fostering business growth.
If you thrive in a fast-paced environment and are eager to make a tangible impact, this opportunity is for you. Apply now to be part of a forward-thinking organization committed to excellence and innovation.
Responsibility
- Develop and implement regulatory strategies to ensure compliance with local and international standards.
- Coordinate product importation processes, including documentation, customs clearance, and logistics.
- Collaborate with R&D and product teams to align innovations with regulatory requirements.
- Monitor and interpret changes in regulations, updating internal policies and procedures accordingly.
- Liaise with government agencies, certification bodies, and external stakeholders to facilitate product approvals.
- Prepare and submit regulatory filings, ensuring accuracy and timeliness.
- Conduct risk assessments and audits to mitigate compliance-related issues.
- Provide training and guidance to internal teams on regulatory matters.
Qualifications
- Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, or a related field.
- Minimum of 3 years of experience in regulatory affairs, product development, or importation.
- Strong knowledge of Indonesian and international regulatory frameworks (e.g., BPOM, FDA, EU regulations).
- Experience in preparing and submitting regulatory documentation.
- Excellent analytical, communication, and project management skills.
- Ability to work independently and collaboratively in a multicultural environment.
- Proficiency in English and Bahasa Indonesia.
- Familiarity with ISO, GMP, or other relevant quality standards is a plus.