Regulatory Affairs Executive
6 months ago
Job Summary
We are seeking a highly motivated and detail-oriented Regulatory Affairs Executive to join our team. In this role, you will be responsible for ensuring compliance with all relevant regulations and standards governing our industry. You will work closely with Amway’s Global Innovation & Science team and collaborate with local cross-functional teams to support product registration, new product development, and ongoing compliance efforts.
**Responsibilities**:
- Granting License from the respective government’s authority to store, import, and distribute Food, Health supplements, Traditional Medicines, and Agriculture products, and support local new product development licenses in corporation with Vendors.
- Granting and maintaining validity of product registration for Food, Health Supplements, and Traditional Medicine from BPOM; and Agriculture from the Ministry of Agriculture.
- Making sure that the registration requirement is completed before submitting to authority to implement Right at the First Time.
- Regularly update the Database which will be used as a reference for QA to ensure Label compliance and Operations (both Warehouse and Stores) for BPOM’s inspection.
- Research, interpret, and stay up to date on regulatory requirements and trends to address potential impacts on the business.
- Provide regulatory guidance and support to cross-functional teams, including R&D, quality assurance, marketing, and regional/global teams.
- Together with QA and Warehouse team to maintain the validity of distribution licenses (i.e. SMKPO), retain sample management, and other related requirements.
- Actively involved in Regulatory and Policy Influence (RPI) for related associations (APSKI, GAPMMI, AmCham) and advocacy engagement with authorities (BPOM, Ministry of Agriculture, Ministry of Industry, Ministry of Trade).
**Qualifications**:
- Bachelor’s degree in Pharmaceutical and holds a pharmacist license; Master's degree is a plus.
- Have around 3 years of experience in regulatory affairs within the nutrition/health products industry.
- Strong understanding of relevant regulations and standards in Indonesia.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively across teams.
- Detail-oriented with a strong focus on accuracy and compliance.
- Proven ability to manage multiple projects simultaneously and prioritize tasks in a fast-paced environment.
- Experience with regulatory submissions and interactions with regulatory agencies (i.e. BPOM, Kementan) is preferred.
- Proficiency in English, both written and verbal.
- Persistence, ability to demonstrate a “can-do” attitude, and willingness to explore new paths toward the dynamic of the regulatory environment.
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