Regulatory Affairs Manager

7 months ago


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 Devices
- Experience in managing Health Authority Interactions and Negotiations
- Experience in reviewing ad promo material, review labels, work with cross functional teams

**Ability to work independently, take initiative and complete tasks to deadlines**

**Ability to work within a matrix team environment**

**Strong written and verbal communication skills with good attention to detail**

**Good organizational skills and demonstrates effective time management**

**Desire to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands**

**Job Types**: Contract, Part-time
Contract length: 48 months

**Salary**: Rp45,000 - Rp50,000 per hour

Expected hours: 80 - 120 per week

**Experience**:

- Pharmaceutical Regulatory Affairs: 8 years (required)
- Medical Devices Regulatory Affairs: 3 years (required)



  • 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...

  • Regulatory Affairs

    3 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...


  • 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 Galderma Full time

    With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the leading company solely dedicated to skin and advancing the future of dermatology. We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all,...


  • 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 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 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 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 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 PT HM Sampoerna Tbk. Full time

    BE A PART OF A REVOLUTIONARY CHANGE At PMI, we’ve chosen to do something incredible. We’re totally transforming our business and building our future on one clear purpose - to deliver a smoke-free future. With huge change, comes huge opportunity. So, wherever you join us, you’ll enjoy the freedom to dream up and deliver better, brighter solutions and...


  • 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 Setara Networks Full time

    We at Indepay | Setara Networks are here to revolutionize the Indonesian payment ecosystem by introducing one click checkout services in order to make transactions zero-fee, instant, and rewarding for the consumer. On one side we’re working with financial institutes to enable real-time account to account transfers through our platform, and on the...


  • 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 Philip Morris International Full time

    **Be a part of a revolutionary change** At PMI, we’ve chosen to do something incredible. We’re totally transforming our business - and building our future on one clear purpose - to deliver a smoke-free future. With huge change, comes huge opportunity. So, wherever you join us, you’ll enjoy the freedom to dream up and deliver better, brighter...


  • Jakarta, Indonesia PT. Ingredion Indonesia Full time

    **Location : Jakarta, Indonesia** **Reports to **:Head, Scientific & Regulatory Affairs, APAC** **Workplace type **:Hybrid** The **Senior Regulatory Affairs Analyst, Global Scientific & Regulatory Affairs, APAC** is responsible for conducting regulatory assessments to enable and support the growth of the Ingredion portfolio. They should have experiences...


  • 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 DSM Full time

    **Job title** - Manager Regulatory Affair, Perfumery & Beauty, Asia Pacific **Location** - Indonesia **Job model **- Hybrid As the Regulatory Affair Manager of Perfumery & Beauty (P&B) responsible of Asia Pacific region (APAC), your primary responsibility will be to ensure regulatory and safety compliance of all P&B products offered in APAC. This involves...

  • Regulatory Affairs

    7 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...


  • 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 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...