Manager Regulatory Affairs

2 weeks ago


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 implementation of regulatory affairs' policies, procedures and standards to ensure alignment with 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, safety, health & environment (SHE), and registration (REG) to ensure consistent implementation and full compliance across the country.
  • Recommend improvements on policies, practices, and processes related to safety, health & environment (SHE) and registration (REG) to ensure the attainment of quality standards.
  • Develop and conduct quality management trainings - safety, health & environment (SHE) and registration (REG) - to enhance employees' awareness of quality and create a culture of continuous improvement.
  • Manage the review with the 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 of Regulatory Affairs and the Senior Managers of Quality Assurance (QA), Safety, Health & Environment (SHE), and Registration (REG) to ensure consistent implementation.

Minimum Qualifications:

  • Minimum five years' experience in a similar role.
  • 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 good working knowledge, comprehension, and applications of local regulations.
  • 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 in Chemistry, Pharma, or related disciplines.

#J-18808-Ljbffr

  • 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, 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, 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, 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, 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 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 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, Jakarta, Indonesia FLOQ Full time

    We are looking for a seasoned Government Relations Expert to lead our regulatory affairs efforts. The successful candidate will have a proven track record in navigating complex regulatory environments.Responsibilities:Analyze and interpret regulatory requirements to inform business decisions.Develop and maintain relationships with key stakeholders, including...


  • Jakarta, Jakarta, Indonesia Cermati Full time

    Cermati Fintech Group is seeking an experienced Regulatory Affairs Specialist to join our team. As a key member of our compliance team, you will be responsible for staying up-to-date with new and updated regulations, identifying potential risks, and developing strategies to ensure compliance.ResponsibilitiesMonitor regulatory developments and analyze their...


  • Jakarta, Jakarta, Indonesia ika Sentosa, Tbk Full time

    iT Dian Swastatika Sentosa Tbk is looking for a Regulatory Affairs Specialist to build and maintain strong relationships with government officials, regulatory agencies, and key stakeholders.The successful candidate will have excellent communication, negotiation, and interpersonal skills, as well as a proven track record of ensuring regulatory compliance.Key...


  • Jakarta, Jakarta, Indonesia Talent Search Recruitment Full time

    Talent Search Recruitment is looking for a seasoned Compliance and Regulatory Affairs Lead to oversee the full registration process for designated brands. This role involves ensuring that all product documentation, ingredients, and labeling comply with BPOM regulations.The successful candidate will lead a dedicated brand-focused team, track key deadlines,...


  • Jakarta, Jakarta, Indonesia Talent Search Recruitment Full time

    We are looking for a skilled Beauty Industry Regulatory Affairs Specialist to join our team at Talent Search Recruitment. In this role, you will be responsible for overseeing the full registration process for designated brands, ensuring compliance with BPOM regulations.The ideal candidate will have excellent leadership skills, strong communication abilities,...


  • Jakarta, Jakarta, Indonesia Wellesta Full time

    We are hiring a Regulatory Affairs Manager to lead the development and implementation of regulatory strategies for drug approvals and lifecycle management at Wellesta CPI.The ideal candidate will have a strong background in regulatory affairs, with experience in preparing and submitting regulatory dossiers (IND, NDA, ANDA, MAA, CTA, etc.).You will work...


  • Jakarta, Jakarta, Indonesia Wellesta Full time

    At Wellesta CPI, we are seeking a highly skilled Regulatory Affairs Manager to join our team. As a Regulatory Affairs Manager, you will play a critical role in developing and implementing regulatory strategies for drug approvals and lifecycle management.The ideal candidate will have a strong understanding of BPOM regulations and system implementation, as...


  • Jakarta, Jakarta, Indonesia PT DKSH Indonesia Full time

    Job RequirementsThis Health Safety Regulatory Officer role requires a Bachelor of Science in Chemistry, Pharma, or related disciplines. The ideal candidate will have demonstrated proficiency in office productivity tools, such as Excel, Word, and PowerPoint.ResponsibilitiesManage the review with the local management team on Regulatory Affairs' activities and...

  • Regulatory Specialist

    2 weeks ago


    Jakarta, Jakarta, Indonesia Center for Indonesia's Strategic Development Initiatives (CISDI) Full time

    We are looking for a skilled Regulatory Specialist to join our team at the Center for Indonesia's Strategic Development Initiatives (CISDI). As a Regulatory Specialist, you will play a key role in analyzing and developing regulatory frameworks that support our mission to improve public health and governance in Indonesia.About the RoleThis is a full-time...


  • Jakarta, Jakarta, Indonesia DKSH Group Full time

    Job OverviewThis role is responsible for managing the local implementation of safety, Pharmacovigilance (PV) and registration (REG) policies and standards.The successful candidate will ensure regulatory compliance to local and international laws and regulations.