Manager Regulatory Affairs

1 week ago


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 international laws and regulations

**General Responsibilities**:

- Manage departmental operating budgets and costs according to annual allocation to ensure efficient usage of resources, where applicable
- Manage the implementation of regulatory affairs' policies, procedures and standards to ensure alignment to global DKSH quality policy and local/international quality standards
- Develop and maintain quality assurance systems, including the development of quality checklists, supporting tools and techniques
- Develop and follow up on corrective and preventive actions on regulatory affairs' activities - quality assurance (QA), safety, health & environment (SHE) and registration (REG) - to ensure consistent implementation and full compliance across the country
- Recommend improvement on policies, practices and processes related to quality assurance (QA), safety, health & environment (SHE) and registration (REG) to ensure the attainment of quality standards
- Develop and conduct quality management trainings - quality assurance (QA), safety, health & environment (SHE) and registration (REG) - to enhance employees' awareness of quality and create a culture of continuous improvement
- Manage the review with local management team on Regulatory Affairs' activities and updates to obtain commitment on local regulatory affairs implementation
- Provide technical advice and support to internal stakeholders on quality management matters
- Support the Head Regulatory Affairs and the Senior Managers Quality Assurance (QA), Safety, Health & Environment (SHE) and Registration (REG) to ensure consistent implementation

**Functional Skills and Knowledge**:

- Demonstrate knowledge in quality assurance tools, concepts and methodologies
- Demonstrate good knowledge in Dangerous Goods Regulations and Safety Data Sheets (SDS)
- Demonstrate basic understanding of the Global Harmonized System (GHS)
- Demonstrate proficiencies in office productivity tools (e.g. Excel, Word and PowerPoint)
- Demonstrate appreciation and respect for cultural sensitivities especially in cross-country/-cultural interactions
- Demonstrate fluency in English, both written and spoken

**Education**:
Bachelor of Science, Chemistry, Pharma or related disciplines

**Why It’s Great to Work at DKSH**:



  • Jakarta, Indonesia DKSH Holding Ltd Full time

    Location: Jakarta, ID, ID - Global Business Unit: HEC - Job Function: Regulatory Services - Requisition Number: 180304 - Description: **Job Summary**: Manage the local implementation of the safety, **Pharmacovigilance (PV)** and registration (REG) policies and standards, guarantee the regulatory compliance to local and international laws and...


  • 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, Jakarta, Indonesia DKSH Group Full time

    Press Tab to Move to Skip to Content LinkSelect how often (in days) to receive an alert:Title: Manager Regulatory AffairsLocation:Jakarta, ID, IDGlobal Business Unit: HECJob Function: Regulatory ServicesRequisition Number: 180304Description:Job SummaryManage the local implementation of the safety, Pharmacovigilance (PV) and registration (REG) policies and...


  • 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, Jakarta, Indonesia PT DKSH Indonesia Full time

    Manage the local implementation of the safety, Pharmacovigilance (PV) and registration (REG) policies and standards, guaranteeing regulatory compliance with local and international laws and regulations.Manage departmental operating budgets and costs according to annual allocation to ensure efficient usage of resources, where applicable.Manage the...


  • Jakarta, Jakarta, Indonesia Michael Page Full time

    The Ideal CandidateThe ideal candidate will possess:A minimum of six years of experience in public policy, government relations, or consulting.A background in top-tier consulting firms, corporate public affairs, or government institutions.A well-established professional network within Indonesia's regulatory and policy landscape.Strong leadership...


  • Jakarta, Indonesia Heineken Full time

    **Job Purpose** Our Corporate Affairs ambition is to grow the business, promote the company, our brands and products and improve the business climate. In close collaboration with Corporate Affairs Director, Corporate Communications Manager and Sustainability Manager, a Public and Regulatory Affairs Manager is expected to deliver the ambition by: - Leading...


  • Jakarta, Jakarta, Indonesia PT DKSH Indonesia Full time

    Job DescriptionThe Regulatory Affairs Manager will be responsible for managing the local implementation of safety, pharmacovigilance, and registration policies and standards. This role requires strong knowledge of local and international regulations to ensure compliance.Key ResponsibilitiesManage departmental operating budgets and costs to ensure efficient...


  • Jakarta, Indonesia Boston Scientific Corporation Full time

    **Regulatory Affairs Specialist**: - Remote Eligible: Hybrid- Onsite Location(s): Jakarta, IDWe are seeking a Regulatory Affairs Specialist for our Indonesia Team. He/she ensures rapid and timely approvals for respective product lines by plans on all product registration, manage all product registrations' preparation and documentation. He/she Interacts with...


  • 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, Jakarta, Indonesia Timephoria Full time

    At Timephoria, we are seeking a highly skilled Regulatory Affairs Manager to join our team.Job DescriptionThe successful candidate will be responsible for ensuring regulatory compliance for product registration, aligning with BPOM and other relevant authorities.They will oversee the BPOM registration process for both new and existing products, guaranteeing...


  • Jakarta, Jakarta, Indonesia Wellesta Full time

    We are looking for a talented Regulatory Affairs Manager to join our team at Wellesta CPI. In this role, you will be responsible for developing and implementing regulatory strategies for drug approvals and lifecycle management.The ideal candidate will have a strong background in regulatory affairs, with experience in preparing and submitting regulatory...


  • Jakarta, Indonesia Boston Scientific Corporation Full time

    **Senior Regulatory Affairs Specialist**: - Remote Eligible: Hybrid- Onsite Location(s): Jakarta, IDWe are seeking a Senior Regulatory Affairs Specialist for our Indonesia Team. He/she ensures rapid and timely approvals for respective product lines by plans on all product registration, manage all product registrations' preparation and documentation. He/she...


  • 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, Jakarta, Indonesia Wellesta Full time

    Direct message the job poster from WellestaHR Generalist | Recruitment | HRBP | We are HiringResponsibilities:Develop and implement regulatory strategies for drug approvals and lifecycle management.Prepare and submit regulatory dossiers (IND, NDA, ANDA, MAA, CTA, etc.).Strong understanding of BPOM regulations and system implementation.Ensure compliance with...


  • Jakarta, Jakarta, Indonesia Timephoria Full time

    Ensure regulatory compliance for product registration, aligning with BPOM and other relevant authorities.Oversee the BPOM registration process for both new and existing products.Guarantee compliance with packaging, labeling, and ingredient approval requirements.Manage warehouse and operational permits and maintain regulatory documents.Work closely with...


  • Jakarta, Jakarta, Indonesia Talent Search Recruitment Full time

    The Regulatory Affairs Lead will oversee the full registration process for designated brands for our client, an established company in the beauty and personal care industry. This role involves ensuring that all product documentation, ingredients, and labeling comply with BPOM regulations, coordinating with regional teams, and managing testing and regulatory...


  • Jakarta, Jakarta, Indonesia Mastercard, Inc. Full time

    Job Title: Regulatory Affairs SpecialistMastercard, Inc. is seeking a seasoned professional to lead our public policy advocacy efforts in Indonesia.OverviewThis role involves developing a public policy strategy and implementable program for Indonesia to lead and respond to regulatory and legislative threats to Mastercard and/or the payment industry.Main...


  • Jakarta, Jakarta, Indonesia Pintu Full time

    Pintu is hiring a Regulatory Affairs Expert to contribute to the success of our Legal, Compliance & Government Relations team.In this role, you'll:Develop and implement regulatory strategies to meet business objectives.Analyze and interpret regulatory requirements to inform compliance decisions.Collaborate with internal teams to ensure alignment with...


  • Jakarta, Indonesia Mondelēz International Full time

    **Job Description**: **Are You Ready to Make It Happen at Mondelēz International?** **Join our Mission to Lead the Future of Snacking. Make It With Pride.** You execute the scientific and regulatory affairs strategy for your respective category or categories and geographical area using your scientific and regulatory expertise and are responsible for the...