26 Financial Regulations jobs in Indonesia
Senior Compliance Officer - Financial Regulations
Posted 2 days ago
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Remote Senior Compliance Officer - Financial Regulations
Posted 2 days ago
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Key responsibilities include interpreting and applying complex financial regulations (e.g., AML, KYC, sanctions screening), developing and delivering compliance training programs, and investigating potential compliance breaches. You will also be involved in updating compliance policies and procedures, responding to regulatory inquiries, and liaising with external auditors and regulators. The ideal candidate will possess a strong understanding of the Indonesian banking and financial regulatory landscape, as well as international best practices. Proactive identification of emerging compliance risks and the development of effective mitigation strategies will be essential. This role requires meticulous attention to detail, strong analytical skills, and the ability to communicate complex regulatory concepts clearly and concisely.
The successful candidate will hold a Bachelor's degree in Law, Finance, Accounting, or a related field, with a minimum of 6 years of experience in compliance, regulatory affairs, or internal audit within the financial services industry. A Master's degree or relevant professional certifications (e.g., CAMS, CRCM) are highly advantageous. Proven experience in developing and managing compliance programs, conducting risk assessments, and performing internal investigations is required. Excellent knowledge of financial regulations, particularly those relevant to banking operations in Indonesia, is mandatory. Strong analytical, problem-solving, and communication skills, along with proficiency in compliance management software and MS Office Suite, are essential. This is an excellent opportunity for a dedicated compliance professional to contribute to a leading financial institution in a flexible, remote setting.
Regulatory Affairs Specialist
Posted today
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Key responsibilities include:
- Developing and implementing regulatory strategies for product registration and compliance.
- Preparing, reviewing, and submitting regulatory documentation to relevant authorities.
- Monitoring and interpreting new and existing regulations and guidelines.
- Communicating with regulatory agencies to facilitate product approvals and resolve compliance issues.
- Ensuring all company activities and products meet regulatory requirements.
- Maintaining regulatory databases and records.
- Conducting internal audits to assess compliance.
- Providing regulatory guidance and training to internal teams.
- Collaborating with R&D, manufacturing, and quality assurance departments.
Pharmaceutical Regulatory Affairs Specialist
Posted 1 day ago
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Regulatory Affairs Specialist - Pharmaceutical
Posted 2 days ago
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Key responsibilities include:
- Preparing, reviewing, and submitting regulatory filings, including Marketing Authorization Applications (MAA), variations, and renewals.
- Interpreting and applying regulatory guidelines and standards relevant to pharmaceutical products.
- Communicating with regulatory authorities (e.g., BPOM) to facilitate the approval process and respond to queries.
- Collaborating with R&D, clinical, manufacturing, and quality assurance departments to gather necessary information for submissions.
- Monitoring changes in regulatory requirements and assessing their impact on company products and processes.
- Ensuring the regulatory compliance of product labeling, promotional materials, and advertising.
- Maintaining regulatory databases and tracking submission status.
- Providing regulatory guidance and support to internal teams.
- Assisting in the preparation for regulatory inspections and audits.
- Contributing to the development and improvement of regulatory affairs processes.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Pharmacology, Chemistry, Life Sciences, or a related field.
- Minimum of 3-5 years of experience in regulatory affairs within the pharmaceutical industry.
- Thorough knowledge of pharmaceutical regulatory requirements in Indonesia (BPOM) and ideally international guidelines (e.g., ICH).
- Proven experience in preparing and submitting regulatory dossiers.
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong written and verbal communication skills, with meticulous attention to detail.
- Ability to manage multiple projects and deadlines effectively.
- Proficiency in regulatory information management systems is a plus.
- Strong understanding of the drug development and lifecycle process.
This hybrid role offers an excellent opportunity to contribute to the pharmaceutical sector in Medan, North Sumatra, ID .
Senior Regulatory Affairs Specialist
Posted 2 days ago
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Key Responsibilities:
- Prepare, review, and submit regulatory dossiers for product registrations, variations, and renewals in accordance with local health authority requirements (e.g., BPOM).
- Interpret and apply regulatory guidelines and policies to ensure product compliance.
- Manage and maintain product regulatory information and documentation.
- Liaise with regulatory authorities and health agencies to facilitate product approvals and address queries.
- Provide regulatory support and strategic guidance to internal teams, including R&D, manufacturing, and marketing.
- Monitor changes in regulations and assess their impact on company products and operations.
- Develop and implement regulatory strategies for new product development and lifecycle management.
- Conduct regulatory compliance audits and assessments.
- Prepare and deliver training on regulatory requirements to relevant personnel.
- Contribute to the development of regulatory submission plans and timelines.
- Ensure all regulatory activities are documented accurately and thoroughly.
- Participate in industry forums and discussions related to regulatory affairs.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
- Minimum of 5-7 years of experience in regulatory affairs within the pharmaceutical industry.
- In-depth knowledge of Indonesian pharmaceutical regulations and guidelines (BPOM).
- Experience with preparing and submitting Common Technical Document (CTD) dossiers.
- Proven ability to manage product registration processes from start to finish.
- Strong analytical and problem-solving skills with meticulous attention to detail.
- Excellent written and verbal communication skills, including proficiency in English and Bahasa Indonesia.
- Ability to interpret complex regulations and apply them practically.
- Experience with regulatory information management systems is a plus.
- Ability to work effectively in a hybrid work environment, balancing independent work with team collaboration.
- Strong project management and organizational skills.
This is a critical role for our client, ensuring compliance and facilitating market access for their vital pharmaceutical products.This is a hybrid role based in Jakarta.
Pharmaceutical Regulatory Affairs Specialist
Posted 2 days ago
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Pharmaceutical Regulatory Affairs Specialist
Posted 2 days ago
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- Preparing, reviewing, and submitting regulatory dossiers for new drug applications and variations.
- Ensuring compliance with national and international pharmaceutical regulations (e.g., FDA, EMA, BPOM).
- Liaising with regulatory authorities, responding to queries, and facilitating regulatory interactions.
- Monitoring changes in regulatory requirements and assessing their impact on company products.
- Managing post-approval changes and ensuring timely submissions.
- Reviewing promotional materials and product labeling for regulatory compliance.
- Participating in regulatory inspections and audits.
- Developing and maintaining regulatory intelligence databases.
- Collaborating with R&D, manufacturing, and marketing teams on regulatory strategy.
- Providing regulatory guidance and support to project teams.
Pharmaceutical Regulatory Affairs Manager
Posted 2 days ago
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As a Pharmaceutical Regulatory Affairs Manager, you will be responsible for ensuring that our client's pharmaceutical products comply with all relevant national and international regulations. You will prepare and submit regulatory filings, liaise with health authorities, and provide strategic guidance on regulatory requirements throughout the product lifecycle. This position requires a comprehensive understanding of pharmaceutical regulations, excellent attention to detail, and strong communication skills.
Responsibilities:
- Develop and implement regulatory strategies for product development and registration.
- Prepare and submit regulatory dossiers (e.g., CTD, IND, NDA) to health authorities.
- Liaise with regulatory agencies (e.g., BPOM) to facilitate approvals and address inquiries.
- Monitor and interpret changes in regulatory landscapes and advise the organization accordingly.
- Ensure compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP).
- Review and approve promotional materials and labeling to ensure regulatory compliance.
- Manage post-approval regulatory activities, including variations and renewals.
- Collaborate with R&D, manufacturing, and marketing teams to support regulatory submissions.
- Provide regulatory training and guidance to internal teams.
- Manage regulatory documentation and databases.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related field.
- Minimum of 5 years of experience in pharmaceutical regulatory affairs.
- In-depth knowledge of Indonesian and international pharmaceutical regulations.
- Proven experience in preparing and submitting regulatory filings.
- Strong understanding of drug development processes and product lifecycle management.
- Excellent written and verbal communication skills.
- Proficiency in regulatory information management systems.
- Ability to work effectively in a hybrid team environment.
- Strong analytical and problem-solving skills.
Senior Regulatory Affairs Specialist
Posted 2 days ago
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Key Responsibilities:
- Develop and implement regulatory strategies to support product development and market access.
- Prepare and submit regulatory applications, dossiers, and amendments to health authorities and relevant bodies.
- Interpret and apply national and international regulations relevant to the company's products and operations.
- Monitor changes in the regulatory landscape and assess their impact on the company.
- Liaise with regulatory agencies, responding to inquiries and facilitating communication.
- Manage product registrations, renewals, and variations.
- Conduct internal audits to ensure compliance with regulatory requirements.
- Provide regulatory guidance and training to cross-functional teams.
- Review and approve marketing materials and product labeling for regulatory compliance.
- Collaborate with R&D, Quality Assurance, and other departments to ensure regulatory requirements are met throughout the product lifecycle.
- Maintain regulatory documentation and databases.
- Bachelor's or Master's degree in a relevant scientific field (e.g., Biology, Chemistry, Pharmacy, Engineering) or Law.
- Minimum of 5 years of progressive experience in regulatory affairs.
- Thorough understanding of regulatory submission processes and requirements in relevant markets.
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong written and verbal communication skills, with the ability to articulate complex regulatory information.
- Proficiency in regulatory information management systems and Microsoft Office Suite.
- Ability to manage multiple projects simultaneously and meet tight deadlines.
- Detail-oriented with strong organizational skills.
- Experience working with regulatory agencies is highly desirable.