Regulatory Affair Officer

CGBio Korea; Jakarta Utara; On-site; IDR 500.333.000 - 667.112.000; Full time

Job summary

A prominent healthcare company in Indonesia is looking for a Regulatory Affairs Officer. This role involves managing the registration processes for medical devices and ensuring compliance with local regulations. Candidates should possess a valid SIPA and have 2–3 years of experience in Regulatory Affairs, particularly in medical devices. The ideal applicant is detail-oriented, organized, and proficient in MS Office. This position offers opportunities for career growth and training with experienced professionals.

Benefits

Top-tier salary structure

Performance-based pay

Specialized training programs

Support for working in Korea

Qualifications

• Minimum 2–3 years of experience in Regulatory Affairs, preferably in medical devices or pharmaceuticals.
• Strong knowledge of Indonesian medical device regulations, CDKAB requirements, and the IPAK registration system.
• Familiarity with halal regulatory processes or willingness to learn.

Responsibilities

• Prepare, compile, and submit registration dossiers for medical devices to the Ministry of Health (MOH).
• Manage and monitor processes related to medical device registration, renewal, and modification.
• Ensure compliance with CDKAB, including documentation, warehouse standards, distribution practices, and internal audits.

Skills

Regulatory Affairs

Attention to detail

Communication

Coordination

Education

SIPA (Surat Izin Praktik Apoteker)

Tools

MS Office

Kemenkes e-Registration system

Job description

Now, it’s your turn to lead the market. Based on 20 years of strong networks and partnerships in Indonesia, Daewoong has introduced the proven sales and marketing system from its Korean headquarters, raising localization and execution to a new level. With systematic, data-driven sales and unique marketing strategies, we create win-win value for both customers and the market. Daewoong has been in Indonesia for over 20 years, deeply understanding the local market and building solid distribution channels and partnerships. Now, with the powerful sales and marketing strategies and systems from Korea, we are beginning a new leap forward. This is why a marketing manager from a global pharmaceutical company recently chose Daewoong. He highly values Daewoong Korea’s localization strategy, execution power, and performance-driven culture, and sees us as a true local company that goes beyond just selling products by also doing tailored R&D and clinical research. At Daewoong, he is expanding his skills through various tasks such as marketing, market analysis, and planning education programs. You too can learn the proven marketing and sales know-how from Korea’s headquarters and take part in creative challenges by applying it to the Indonesian market. In sales, based on proven products and long-standing partnerships, you will join solution-based sales activities with strategic sales and data-driven customer management, creating win-win value for both customers and the market. Daewoong Indonesia’s marketing and sales team is just beginning its big leap. Many more opportunities and growth paths are opening up. More important than experience are attitude and action. For those who want to learn quickly, challenge themselves, and grow, this is the perfect time. With 20 years of built trust as the foundation, the next success story will be written by you.

Your Role in This Journey

• Prepare, compile, and submit registration dossiers for medical devices to the Ministry of Health (MOH).
• Manage and monitor processes related to medical device registration, renewal, and modification.
• Maintain company regulatory licenses such as IPAK (Izin Penyalur Alat Kesehatan), and support other business licenses as required.
• Ensure compliance with CDKAB (Cara Distribusi Alat Kesehatan yang Baik), including documentation, warehouse standards, distribution practices, and internal audits.
• Coordinate and manage halal requirement assessments, including identifying products requiring halal certification, preparing registration documents, and liaising with BPJPH/LPPOM MUI where needed.
• Ensure company compliance with all applicable Ministry of Health (Kemenkes) regulations regarding medical device distribution and post-market activities.
• Serve as the responsible pharmacist (Apoteker Penanggung Jawab) to support company regulatory and distribution activities.
• Maintain and update documentation related to SIPA, ensuring its compliance with local health authority standards.
• Liaise with regulatory bodies and handle communications with Kemenkes, BPOM (if applicable), BPJPH, and other relevant agencies.
• Monitor and interpret regulatory updates (including halal and CDKAB changes), ensuring internal procedures align with current laws.
• Provide regulatory advice to internal stakeholders regarding new product introductions or changes.
• Support audits, inspections, halal audits, and post-market surveillance activities.

Who We’re Excited to Meet

• Possess a valid and active SIPA (Surat Izin Praktik Apoteker) that can be used by the company.
• Minimum 2–3 years of experience in Regulatory Affairs, preferably in medical devices or pharmaceuticals.
• Strong knowledge of Indonesian medical device regulations, CDKAB requirements, and the IPAK registration system.
• Familiarity with halal regulatory processes or willingness to learn.
• Good communication and coordination skills with regulatory authorities.
• Detail-oriented, organized, and capable of working with deadlines.
• Proficient in MS Office and familiar with Kemenkes e-Registration system.

• Preferred: Experience handling Class B–D medical devices.
• Experience in halal compliance or handling halal-certified products.
• Familiar with importation processes and post-market reporting.
• Experience working in a medical device or pharmaceutical distribution company.

Our Commitment at Daewoong

• [Top Treatment & Performance-based Incentive]
• Top-tier salary structure
• Performance-based pay system: Rewards based on achievements, with promotions tied to skills and competencies.
• [A Growth Platform for Your Career Jump]
• Regular provision of specialized training
• Hands-on lectures in collaboration with Korean experts
• Firsthand experience of the latest K-Beauty trends
• Application of the latest Korean cosmetics
• [Opportunity for Global Stage Experience]
• Korea trip support for top performers
• Provision of opportunities to work in Korea for outstanding talents

Life, Work, and Everything in Between

At Daewoong, we want to be more than just a workplace; we strive to be a place where your life finds joy and meaningful growth. We support you fully so that work and life balance harmonizes, and you can shine through every challenge. We hope the time you spend with us becomes a meaningful journey, where shared growth lights up your future.

• Internal & external training programs
• Language training support
• Company events (workshops, HR Day, etc.)
• Employee club activity support
• Long-service awards
• Employee discount on B-Project services and products
• Additional private insurance support
• Congratulatory and condolence payments
• Performance bonus
• Smart Work (Flexible Working Hours)
• Clean and safe working environment
• 40 hours per week, 5 days
• Sick leave, maternity leave, paternity leave, wedding leave, condolence leave, etc.

Meet Your New Work Family

Daewoong Group

Daewoong Group is a major global healthcare leader from Korea, operating in diverse fields including pharmaceuticals, biotechnology, medical devices, and health supplements. With a presence in over 100 countries and a network of 8 branches across Asia and the US, Daewoong drives innovation through 5 worldwide R&D centers and partners with more than 100 companies globally. In Indonesia, Daewoong employs over 360 talented professionals working across multiple locations including Jakarta, Bali, Bekasi, and Surabaya. We are committed to expanding our business further while considering Indonesia a trusted partner growing together. Daewoong actively invests in talent development and contributes to local communities through various CSR initiatives focused on education, health, and social welfare. By joining Daewoong, you become part of a company with the scale, vision, and resources to empower your career and make a global impact in healthcare.

Global Presence

Founded in 1945, a global healthcare leader

Top in overseas subsidiaries among Korean pharma

8 Branch Operations in Asia & US

5 R&D Centers Worldwide

100+ Partners Worldwide

No.1 pharmaceutical company in Korea

Over 4,500 employees in Korea

100+ Indonesian Talents Working in Korea

360+ Employees in Daewoong Indonesia

Celebrating Our Journey

Award by the Indonesian Government (2022)

'Best Workplace' in Korea (2022)

Recognition for Women-Friendly Corporate

Culture & Diversity Management Award (2022)

Global Pharmaceutical R&D Innovation Award (2021)

A Medical Partnership Where Korean and Indonesian Healthcare Professionals Grow Together

CBI supplies a wide range of medical aesthetic and healthcare products, including spinal and bone substitutes, hyaluronic acid (HA) fillers, anti-adhesion agents, and foam dressings, providing advanced medical solutions to the people of Indonesia. Since our establishment in 2022, we have maintained continuous collaboration and education with local healthcare professionals through domestic and international conferences, the Meet the Master program, and global webinars. We place special focus on enhancing product knowledge and procedural skills in the field of cosmetic and aesthetic treatments. We plan to build the CG MedTech Innovation Campus (CIC), a medical device manufacturing facility in Cikarang, with construction scheduled to begin in 2026. This facility will have the capacity to produce 6 million hyaluronic acid fillers annually and will pursue halal certification and local approvals in compliance with Indonesian product protection laws. Moving forward, we will continue to contribute to the health and quality of life of many by combining advanced technology with locally tailored solutions.

Nulook Clinic

Nulook Clinic combines excellent Korean medical technology with local expertise to become a leading hub for K-Beauty and anti-aging. Nulook helps clients enjoy a new and healthier life through cosmetic surgery and stem cell treatments. We are committed to making high-quality Korean aesthetic medical services easily accessible in Indonesia, raising the standard of local healthcare. We aim to be the No.1 center for global petit procedures, body contouring, and stem cell therapy, providing safe and high-quality medical care.

Recruitment Details

Recruitment Process

Application > Aptitude Test > 1st Interview > 2nd Interview > Compensation Negotiation > Final Onboarding

Your growth is our goal

At Daewoong, we place the highest priority on employee growth, providing an environment where you can work with autonomy and deep immersion. Regardless of age, tenure, gender, or nationality, we evaluate fairly, objectively, and transparently based on ability and performance, and reward accordingly. We strive to build a company where every employee feels a true sense of ownership. We believe our work becomes truly meaningful only when the growth of our people leads to the growth of our customers and society. This is what we call a true win-win-win. Daewoong is a place full of opportunities for your growth. We look forward to sharing this journey of challenge and growth with you.

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At CG Bio Indonesia, we combine medical science and beauty to deliver advanced solutions. Our products include HA fillers, bone grafts, anti-adhesion agents, and foam dressings. We support Indonesian doctors through training and collaboration to ensure better outcomes. To boost local innovation, we\'re building the CGMedTech Innovation Campus in Cikarang to produce 500,000 HA fillers monthly. Alongside this, our NuLook Clinic offers premium K-Aesthetic treatments and medical training — setting new standards in beauty and care.

At CG Bio Indonesia, we combine medical science and beauty to deliver advanced solutions. Our products include HA fillers, bone grafts, anti-adhesion agents, and foam dressings. We support Indonesian doctors through training and collaboration to ensure better outcomes. To boost local innovation, we\'re building the CGMedTech Innovation Campus in Cikarang to produce 500,000 HA fillers monthly. Alongside this, our NuLook Clinic offers premium K-Aesthetic treatments and medical training — setting new standards in beauty and care.