About us

Established in 2022, INSIGHTOF Corporation is a distinguished regulatory service provider with a wealth of experience supporting pharmaceutical, cosmetic, and medical companies on both local and international fronts. Our specialization lies in streamlining the product registration process, securing crucial approvals for marketing and distribution within the regions of Indonesia and Malaysia.

 

 

Qualifications & experience

• Min Bachelor's Degree (S1) in Pharmacy (Pharmacist), with an active and ready-to-use STR (if needed).
• 1-2 years of experience in regulatory affairs in the pharmaceutical industry (product registration of Medicines/Supplements/Herbal/Food and Beverages).
• Strong knowledge of regulatory requirements, including BPOM, Kemenkes, as well as knowledge of FDA, EMA, and other international regulatory bodies' requirements is preferred.
• Excellent understanding of BPOM drug product registration systems (E-Reg BPOM, ASROT, New AeRO, Notifkos, etc.).
• Always up-to-date with government regulations (BPOM, HALAL, SNI).
• Understanding of SKI submissions and Surveyor Reports for product importation permits.
• Highly qualified individual with good analytical thinking, communication skills, attention to detail, and the ability to work in a team.
• Proficiency in English.

 

 

Tasks & responsibilities

• Manage all registration document submissions to regulatory bodies (BPOM, Ministry of Health, BPJPH) for the approval of NIE (new products) or renewals (existing products).
• Conduct product registrations with BPOM/Ministry of Health.
• Monitor the submission status within the regulatory body registration systems (BPOM/Ministry of Health) and ensure all products are registered on time.
• Ensure products being sold comply with applicable regulations.
• Coordinate with internal and external teams (BPOM/Ministry of Health/OSS/Local Health Department/BBPOM, etc.).
• Handle the company's STR and SIP as needed.
• Ensure all documents required for registration are valid and meet BPOM requirements.
• Prepare and be responsible for DIP (Product Information Document) for BPOM audit purposes.
• Understand the Halal product submission process to BPJPH.

Growth Opportunities Impactful Work Supportive Culture What's your expected monthly basic salary? Which of the following Microsoft Office products are you experienced with? How would you rate your English language skills? How much notice are you required to give your current employer? Are you available to travel for this role when required? Are you available to work outside your usual hours when required? (e.g. weekends, evenings, public holidays) Which of the following languages are you fluent in? How many years' experience do you have as a Regulatory Staff?