Regulatory Affairs

2 months ago


Jakarta, Indonesia LeaderMed Group Full time

Responsible for managing and submitting regulatory filing materials, communicating with government departments, and handling matters related to regulatory filing strategies.
- Ensure compliance with local, national, and international regulatory requirements for company products, and develop **Corporate Regulatory Manuals & Guidelines** as company standards and procedures.
- Act as a liaison between the company and regulatory authorities, stay up-to-date with regulatory changes, and communicate the implications to relevant stakeholders.
- **Regulatory Compliance**: Supervise and audit product compliance with local production and operation regulations in the target country.
- **Registration and Certification Management**: Manage the registration process, including preparing and submitting necessary documentation to regulatory authorities, and coordinate with inspection agencies for product testing and certification.

**Job Requirements**:

- Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Biology, Biotechnology, or a related field.
- At least 3 years of experience in regulatory affairs or a related position,
- Proven experience in quality management systems, safety, and occupational health management, preferably in a manufacturing or industrial environment.
- Experience in handling **drugs registration is a must**, medical devices/food supplement related experience is a plus.
- Proficiency in managing intellectual property, including patents and trademarks.
- Strong analytical and problem-solving skills, negotiation abilities, and attention to detail.
- Maintain good relationships with BPOM (Indonesian FDA) and the Ministry of Health.
- Ability to lead and conduct internal audits and management reviews.
- Excellent verbal and written communication skills in English and Bahasa.
- Willing to work full-time from the office in jakarta.

**Education**:

- S1 (preferred)

**Experience**:

- Regulatory Affairs: 3 years (required)

**Language**:

- english (required)

**Location**:

- Jakarta (required)


  • Regulatory Affair

    5 months ago


    Jakarta, Indonesia PT JADE ABADI JAYA Full time

    Tugas dan Tanggungjawab Regulatory Affairs: 1. Pemahaman Peraturan dan Perundangan: Tugas utama dari Regulatory Affairs adalah memahami dan mengikuti peraturan dan perundangan yang berlaku di Indonesia. Ini melibatkan pemantauan dan pemahaman terhadap peraturan yang dikeluarkan oleh otoritas regulasi terkait. 2. Perizinan dan Registrasi: Regulatory Affairs...


  • Jakarta, Indonesia DKSH Full time

    **Location**:Jakarta, ID, ID**Job Function**:Regulatory Services**Requisition Number**:137312**Description**: **Job Summary** Manage the local implementation of the company quality assurance (QA), safety, health & environmental (SHE) and registration (REG) policies and standards, guarantee the regulatory compliance to local and international laws and...


  • Jakarta, Indonesia Johnson & Johnson Full time

    Johnson & Johnson is recruiting a Regulatory Affairs Specialist based in Indonesia The Regulatory Affairs Specialist, Medical Device, Indonesia, is a member of the local Regulatory Affairs department, responsible for actively contributing to the regulatory compliance of medical devices under their responsibility. The position is responsible for providing...


  • Jakarta, Indonesia Artixio Consulting Pvt Ltd Full time

    10+ years of regulatory affairs experience in the pharmaceutical and medical devices industry **Prior experience preparing and reviewing submissions to BPOM** - Experience in Submission of New Drug Applications, Generic Drug Applications, Medical Devices Registration - Experience in Post Marketing Maintenance, Lifecycle Management of Marketed Drugs and...


  • Jakarta, Indonesia PepsiCo Full time

    Overview: **About the job**: To strengthen our growth, we are looking for talent as Regulatory Affairs Compliance Manager **What can you expect?** Own the regulatory compliance work and regulatory work for each innovation projects for food and beverage business in Indonesia to run formula & ingredient compliance assessment, develop product labelling...


  • Jakarta, Indonesia DKSH Full time

    **Location**:Jakarta, ID, ID**Job Function**:Regulatory Services**Requisition Number**:156030**Description**: **Job Summary** Supervise the execution of company quality assurance (QA), safety, health & environmental (SHE) and registration (REG) policies and standards, guarantee the regulatory compliance to local and international laws and...


  • Jakarta, Indonesia International Flavors & Fragrances Full time

    Are you passionate about Regulatory Affairs? Would you love to work for a global organization that is doing more good for people and planet? Joining science and creativity, we are an international collective of thinkers who partner with customers to bring scents, tastes, experiences, ingredients and solutions for products the world craves. We have an...


  • Jakarta, Indonesia Amway Inc. Full time

    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...


  • Jakarta, Indonesia DKSH Full time

    Location: Jakarta, ID, ID- Global Business Unit: PM- Job Function: Regulatory Services- Requisition Number: 166789- Description: **Job Summary**: Manage the local implementation of the company quality assurance (QA), safety, health & environmental (SHE) and registration (REG) policies and standards, guarantee the regulatory compliance to local and...


  • Jakarta, Indonesia PT Tentang Anak Bahagia Full time

    **About Tentang Anak** Imagine a career where you play a pivotal role in ensuring the success and bright future of 80 million children in Indonesia. Tentang Anak is not just a company; it's a mission, a movement, and an opportunity to be part of something truly extraordinary. Our products are the one and only in Indonesia that are developed by experts,...


  • Jakarta, Indonesia Nestle Operational Services Worldwide SA Full time

    **Position Snapshot** Location: Jakarta, Head Office **Position Summary** Joining Nestlé means you are joining the largest food and Beverage Company in the world. At our very core, we are a human environment - passionate people driven by the purpose of unlocking the power of food to enhance quality of life for everyone, today and for generations to...


  • Jakarta, Indonesia PT. Merhati Keluarga Medika Full time

    PT. Merhati Keluarga Medika is a healthcare company that focuses in innovative pharmaceutical and medical device products. We are now seeking a _**Regulatory Affairs Officer & PJT **_as the team continues to grow and develop into its next phase. **I. Qualifications & Requirements** - At least 2 (two) years of relevant experience in regulatory affairs in a...


  • Jakarta, Indonesia Humana International Full time

    **Responsibilities**: - ** Develop relationships with National and Local Customs, Quarantine Bureau, Air **Defense**, CAAC, SAA and other regulatory authorities.**: - ** Develop and implement a Customs & Regulatory strategy that facilitates improvements in Customs Clearance and Operational Performance, Productivity and Cost in the medium to long...


  • Jakarta, Indonesia Medtronic Full time

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. **A Day in the Life **:We are a learning culture. An inventive and collaborative group. We are dedicated to making...


  • Jakarta, Indonesia PT Humana International Indonesia Full time

    **Responsibilities**: - **Develop relationships with National and Local Customs, Quarantine Bureau, Air Defense, CAAC, SAA and other regulatory authorities.**: - **Develop and implement a Customs & Regulatory strategy that facilitates improvements in Customs Clearance and Operational Performance, Productivity and Cost in the medium to long term.**: -...


  • Jakarta, Indonesia PT. Ultra Sakti Full time

    1. Pendidikan mínimal Apoteker, IPK min. 3 (Skala 4) 2. Pengalaman mínimal 2 tahun di bidang Regulatory Affairs Officer **3. Keterampilan yang harus dimiliki**: bicara & menulisa dalam bahasa Inggris, datail, komunikasi, ketelitian, dan kerjasama 4. Memiliki keinginan tinggi untuk belajar **5. Penempatan kerja**: Bekasi "Waspada terhadap Modus Penipuan...

  • Regulatory Affairs

    5 months ago


    Jakarta, Indonesia BAXTER Full time

    **This is where you save and sustain lives** At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...

  • Regulatory Affairs

    5 months ago


    Jakarta, Indonesia WeNetwork Asia Full time

    Our client is a B2B cosmetic company. As part of their business growth, they are currently looking for experienced Regulatory Affairs to increase their operations **Key Responsibilities**: - Reviewing cosmetics products regulations in Indonesia - Ensure all products have distribution permit - Monitoring all products sold have the right information on PDP -...


  • Jakarta, Indonesia DHL Full time

    **Role Summary** Plan, direct and monitor customs and regulatory affairs activities so the organization has the permits, licenses, certificates, authorization, and other approval needed to conduct current and future business activities. **Main Responsibilities-** - Identify, develop, and prioritize initiative to continuously enhance the operating...


  • Jakarta, Indonesia Sante International Full time

    Job Overview: Key Responsibilities: - Stay abreast of current regulations, guidelines, and industry trends to ensure compliance and provide regulatory guidance to project teams. - Assist in the preparation and review of labeling, promotional materials, and other product-related documents to ensure compliance with regulatory requirements. - Participate in...