31 Technical Regulations jobs in Indonesia
Senior Legal Counsel - Compliance
60111 Surabaya, East Java
IDR32000000 month
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Our client is actively seeking a highly experienced Senior Legal Counsel specializing in Compliance to join their legal team in a fully remote capacity. This role is pivotal in ensuring the company operates in full adherence to all relevant legal and regulatory requirements across its diverse business activities. You will be instrumental in developing, implementing, and overseeing the company's compliance programs, conducting risk assessments, and providing expert guidance on regulatory matters. The ideal candidate possesses a deep understanding of compliance frameworks and a proactive approach to risk mitigation.
Key responsibilities include:
Key responsibilities include:
- Developing, implementing, and managing the company's comprehensive compliance program.
- Conducting regular risk assessments and identifying potential areas of compliance vulnerability.
- Ensuring adherence to all applicable laws, regulations, and industry standards.
- Advising senior management on compliance strategies and best practices.
- Developing and delivering compliance training to employees across all departments.
- Investigating compliance breaches and recommending appropriate remedial actions.
- Monitoring regulatory changes and updating compliance policies and procedures accordingly.
- Managing relationships with regulatory bodies and external auditors.
- Overseeing internal controls and ensuring their effectiveness.
- Assisting with the development and implementation of ethical business conduct policies.
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Senior Legal Counsel - Compliance
90111 Makassar, South Sulawesi
IDR28000000 month
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Our client is seeking an accomplished Senior Legal Counsel specializing in Compliance to join their fully remote legal team. This role is pivotal in ensuring adherence to all relevant laws, regulations, and internal policies across the organization. You will be instrumental in developing, implementing, and managing robust compliance programs. Your responsibilities will include conducting risk assessments, investigating potential compliance breaches, and developing remediation plans. You will stay current with evolving regulatory landscapes and provide expert guidance to business units on compliance strategies. This position requires a meticulous approach to detail, strong analytical skills, and the ability to interpret complex legal and regulatory texts. You will collaborate with internal stakeholders, including legal, audit, and operational teams, to foster a culture of compliance. The ideal candidate is a seasoned legal professional with a deep understanding of corporate compliance, risk management, and regulatory affairs, capable of working independently and driving initiatives forward from a remote setting. Experience in developing and delivering compliance training programs is highly desirable.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Develop, implement, and maintain comprehensive compliance programs.
- Conduct regular compliance risk assessments and audits.
- Investigate alleged violations of laws, regulations, and company policies.
- Develop and execute corrective action plans to address compliance deficiencies.
- Monitor changes in laws and regulations and advise on their impact.
- Provide legal guidance on compliance matters to all levels of the organization.
- Develop and deliver compliance training and awareness programs.
- Manage relationships with regulatory bodies.
- Draft and update compliance policies and procedures.
- Ensure adherence to data privacy regulations (e.g., GDPR, local equivalents).
- Promote ethical conduct and a strong compliance culture throughout the company.
Qualifications:
- Law degree (Sarjana Hukum) from a recognized institution.
- Admitted to the Indonesian Bar and in good standing.
- Minimum of 9 years of legal experience, with a significant focus on compliance and regulatory matters.
- Deep understanding of corporate governance, risk management, and compliance frameworks.
- Proven experience in developing and implementing compliance programs.
- Excellent analytical, research, and problem-solving skills.
- Exceptional written and verbal communication skills in English and Bahasa Indonesia.
- Ability to interpret and apply complex legal and regulatory requirements.
- Proficiency in legal research tools and compliance management software.
- Demonstrated ability to work independently and manage complex projects remotely.
- High level of integrity and ethical standards.
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1
Pharmaceutical Regulatory Affairs Manager
80361 Denpasar, Bali
IDR16 month
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Our client is seeking an experienced Pharmaceutical Regulatory Affairs Manager to join their team in **Denpasar, Bali, ID**. This hybrid role allows for a balance between in-office collaboration and remote work, fostering a productive and adaptable work environment.
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:
Qualifications:
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.
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2
Senior Regulatory Affairs Specialist
75111 Samarinda, East Kalimantan
IDR9500000 month
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Our client is seeking a highly qualified and experienced Senior Regulatory Affairs Specialist to join their team in Samarinda, East Kalimantan, ID . This role is pivotal in ensuring that all products and operations comply with relevant industry regulations and standards. The ideal candidate will possess a deep understanding of regulatory frameworks, a meticulous approach to documentation, and the ability to navigate complex compliance requirements. Responsibilities include preparing and submitting regulatory filings, liaising with regulatory agencies, monitoring changes in regulations, and advising internal teams on compliance matters. You will also be responsible for developing and implementing regulatory strategies, conducting compliance audits, and managing product registrations. A bachelor's degree in a relevant scientific field (e.g., Biology, Chemistry, Pharmacy) or Law is preferred, along with a minimum of 5 years of experience in regulatory affairs, preferably within the (Specify Industry, e.g., pharmaceutical, medical device, food and beverage) sector. Excellent analytical, communication, and project management skills are essential. The ability to interpret and apply complex regulatory guidelines is critical for success in this role. Join our dedicated team and play a key role in maintaining our company's commitment to quality and compliance.
Key Responsibilities:
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.
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3
Pharmaceutical Regulatory Affairs Specialist
70111 Banjarmasin, South Kalimantan
IDR19000000 month
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Our client, a growing pharmaceutical company, is actively seeking a skilled Pharmaceutical Regulatory Affairs Specialist. This hybrid role offers a dynamic work environment, combining remote flexibility with essential team collaboration and on-site requirements as needed. You will be integral in ensuring our pharmaceutical products meet all global regulatory standards and compliance requirements for market approval and ongoing lifecycle management. Your responsibilities will include preparing and submitting regulatory filings, such as NDAs, ANDAs, and variations, to health authorities worldwide. You will also be responsible for maintaining regulatory documentation, responding to queries from regulatory agencies, and monitoring changes in regulatory landscapes. Collaborating closely with R&D, clinical operations, and quality assurance teams to provide regulatory guidance and support throughout the product development process is crucial. The ideal candidate will possess a Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline, with a minimum of 3-5 years of experience in pharmaceutical regulatory affairs. A thorough understanding of ICH guidelines, FDA, EMA, and other relevant regulatory frameworks is essential. Strong analytical, organizational, and written/verbal communication skills are required. Experience with regulatory submission software and a keen eye for detail are vital. This role offers a challenging and rewarding opportunity to contribute to bringing life-changing medicines to patients, navigating the complex world of pharmaceutical regulations.
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4
Senior Regulatory Affairs Specialist
10110 Jakarta Pusat, Jakarta
IDR140000000 Annually
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Our client, a dynamic pharmaceutical company, is seeking a highly experienced Senior Regulatory Affairs Specialist to join their team in Jakarta . This role requires a meticulous professional with a deep understanding of global pharmaceutical regulatory requirements and a proven ability to navigate complex submission processes. The Senior Regulatory Affairs Specialist will be responsible for developing and executing regulatory strategies for drug development and marketing authorization applications across various international markets. This includes preparing and compiling comprehensive dossiers for submission to health authorities such as the FDA, EMA, and local Indonesian regulators. You will collaborate closely with R&D, clinical operations, quality assurance, and marketing departments to ensure that all regulatory documentation is accurate, complete, and compliant with current guidelines. Key responsibilities involve interpreting regulatory guidelines, assessing the impact of new regulations on ongoing projects, and providing expert advice to internal stakeholders. The role also entails managing post-approval changes, annual reports, and lifecycle management activities for approved products. The ideal candidate will possess excellent analytical, written, and verbal communication skills, with a keen eye for detail and a proactive approach to problem-solving. This is a hybrid role, offering a blend of remote flexibility and in-office collaboration to foster team synergy and facilitate complex discussions. You will contribute to the company's success by ensuring timely and efficient regulatory approvals, thereby bringing vital medicines to patients.
Responsibilities:
Responsibilities:
- Develop and implement global regulatory strategies for pharmaceutical products.
- Prepare and submit regulatory dossiers (e.g., INDs, NDAs, MAAs) to health authorities worldwide.
- Ensure compliance with all applicable regulatory requirements and guidelines.
- Review and approve labeling, promotional materials, and other regulated communications.
- Manage post-approval regulatory activities and lifecycle management.
- Liaise with regulatory agencies and respond to inquiries.
- Provide regulatory guidance and support to internal project teams.
- Assess the impact of regulatory changes on company operations.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
- Minimum of 7 years of experience in pharmaceutical regulatory affairs.
- Demonstrated experience with global regulatory submissions and health authority interactions.
- Strong knowledge of pharmaceutical development, manufacturing, and quality systems.
- Excellent understanding of ICH guidelines and regional regulatory requirements.
- Proficiency in regulatory information management systems.
- Strong analytical, problem-solving, and project management skills.
- Effective communication and interpersonal skills, with the ability to collaborate across departments.
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5
Remote Legal Counsel - Compliance Specialist
25115 Padang, West Sumatra
IDR25000000 Annually
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Our client is seeking a highly skilled and experienced Remote Legal Counsel specializing in Compliance to join their legal department. This position is fully remote, allowing you to work from anywhere, and will focus on ensuring the company adheres to all relevant laws, regulations, and internal policies. You will play a crucial role in maintaining the integrity and ethical standards of the organization.
Responsibilities:
Responsibilities:
- Provide expert legal advice and guidance on a wide range of compliance matters, including data privacy, anti-corruption, and industry-specific regulations.
- Develop, implement, and maintain comprehensive compliance programs and policies across the organization.
- Conduct internal investigations into potential compliance violations and recommend corrective actions.
- Review and draft corporate agreements, contracts, and other legal documents to ensure compliance and mitigate risk.
- Stay up-to-date with evolving legal and regulatory landscapes, assessing their impact on the business.
- Advise on risk management strategies and assist in the development of risk mitigation plans.
- Deliver training and educational sessions to employees on compliance-related topics.
- Collaborate with internal departments to ensure adherence to legal requirements in business operations.
- Manage regulatory filings and interactions with government agencies as needed.
- Assist in the development and implementation of ethical guidelines and codes of conduct.
- Monitor the effectiveness of compliance programs and recommend improvements.
- Handle ad-hoc legal requests and projects as assigned by senior management.
- Ensure all legal documentation is accurately maintained and accessible.
- Provide support on litigation matters when required, liaising with external counsel.
- Contribute to the continuous improvement of legal and compliance processes.
- Juris Doctor (JD) or equivalent law degree from a reputable institution.
- Admission to the Bar and in good standing.
- Minimum of 6 years of relevant legal experience, with a strong focus on corporate compliance, regulatory affairs, or risk management. Experience gained in a reputable law firm or in-house legal department is highly valued.
- In-depth knowledge of relevant national and international laws and regulations applicable to our industry.
- Proven experience in developing and implementing compliance programs.
- Excellent analytical, research, and problem-solving skills.
- Strong negotiation and drafting skills for legal documents.
- Exceptional communication and interpersonal skills, with the ability to explain complex legal concepts clearly.
- High degree of professionalism, integrity, and ethical conduct.
- Ability to work independently and manage a remote workload effectively.
- Proficiency in legal research databases and standard office software.
- Fluency in English is mandatory; proficiency in Bahasa Indonesia is a strong asset.
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6
Senior Regulatory Affairs Specialist - Pharmaceuticals
35117 Bandar Lampung, Lampung
IDR17000000 month
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Our client, a leading pharmaceutical company, is seeking an experienced Senior Regulatory Affairs Specialist to join their team in **Bandar Lampung, Lampung, ID**. This critical role involves managing the regulatory submission process for new drug applications, variations, and renewals, ensuring compliance with local and international pharmaceutical regulations. The ideal candidate will possess a strong understanding of regulatory frameworks, a meticulous eye for detail, and excellent communication skills to liaise with health authorities and internal stakeholders.
Key Responsibilities:
Key Responsibilities:
- Prepare, review, and submit regulatory dossiers for drug product registration and variations.
- Ensure compliance with Indonesian regulatory requirements (BPOM) and relevant international guidelines.
- Liaise with regulatory agencies, including health authorities, to facilitate the approval process.
- Interpret and apply regulatory guidelines to product development and lifecycle management.
- Develop and implement regulatory strategies to support company objectives.
- Monitor changes in regulatory legislation and assess their impact on the company's products.
- Provide regulatory guidance and support to cross-functional teams, including R&D, quality assurance, and marketing.
- Manage post-approval regulatory commitments and maintenance activities.
- Contribute to the development and improvement of regulatory processes and systems.
- Maintain regulatory intelligence and databases.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Master's degree or PharmD is a plus.
- Minimum of 5-7 years of experience in regulatory affairs within the pharmaceutical industry.
- In-depth knowledge of Indonesian pharmaceutical regulations (BPOM) and international regulatory requirements (e.g., ICH, FDA, EMA).
- Proven experience in preparing and submitting Common Technical Document (CTD) modules.
- Strong understanding of drug development processes and manufacturing.
- Excellent analytical, problem-solving, and critical-thinking skills.
- Proficiency in regulatory information management systems.
- Strong written and verbal communication skills, with excellent attention to detail.
- Ability to work independently and collaboratively in a team environment.
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7
Remote Pharmaceutical Regulatory Affairs Associate
10110 Jakarta Pusat, Jakarta
IDR16000000 month
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Our client, a dynamic player in the pharmaceutical sector, is looking for a dedicated Remote Pharmaceutical Regulatory Affairs Associate to join their expanding team. This fully remote position allows you to contribute to critical regulatory submissions and compliance activities from any location, supporting a company with significant operations and interests in regions like **Jakarta, Jakarta, ID**. You will be responsible for assisting in the preparation, review, and submission of regulatory documentation required for drug product registrations, amendments, and annual reports in various international markets. This includes compiling dossiers, ensuring adherence to specific country regulations and guidelines, and managing submission timelines to meet regulatory deadlines. A key part of your role will involve staying abreast of evolving regulatory landscapes, guidelines, and policies impacting the pharmaceutical industry, and communicating these changes to relevant internal stakeholders. You will liaanise with regulatory health authorities as needed, respond to queries, and track the status of submissions. The ideal candidate will possess a strong understanding of pharmaceutical product development and the global regulatory submission processes. Excellent organizational skills, meticulous attention to detail, and the ability to manage multiple tasks simultaneously are crucial. You will need to demonstrate strong written and verbal communication skills, as well as proficiency in regulatory information management systems and common office software. A Bachelor's degree in Pharmacy, Pharmacology, Biotechnology, or a related life science field is required. Prior experience (2-4 years) in regulatory affairs within the pharmaceutical industry, preferably with exposure to international submissions, is highly desirable. This remote opportunity is ideal for professionals eager to advance their careers in regulatory affairs within a supportive and growth-oriented environment.
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Remote Legal Counsel, Regulatory Affairs
16313 Cimahi, West Java
IDR22000000 month
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Our client, a rapidly expanding pharmaceutical company with a global reach, is seeking a highly qualified and experienced Remote Legal Counsel specializing in Regulatory Affairs to join their legal department. This is a fully remote position, offering flexibility and the opportunity to contribute to critical regulatory compliance efforts for our operations in Depok, West Java, ID . You will be responsible for providing comprehensive legal guidance on all aspects of pharmaceutical regulatory law, including drug approvals, marketing, advertising, and post-market surveillance. Your role will involve reviewing and advising on regulatory submissions, interacting with health authorities (such as BPOM), and ensuring compliance with national and international pharmaceutical regulations. You will also support the development and implementation of regulatory strategies for new product launches and existing products. The ideal candidate will possess a Juris Doctor (J.D.) or equivalent law degree, admission to the Indonesian Bar (PERADI), and a minimum of 6 years of experience in pharmaceutical regulatory law, preferably within a law firm or in-house at a pharmaceutical company. A strong understanding of intellectual property law as it relates to pharmaceuticals is also highly valued. Exceptional research, analytical, and communication skills are paramount, as is the ability to navigate complex legal and regulatory landscapes. As a remote professional, you must demonstrate strong organizational and self-management skills, with a proven ability to work autonomously and collaboratively with global teams. This is an exciting chance to play a key role in ensuring our client's products meet stringent regulatory standards and reach patients safely and effectively.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Provide expert legal advice on Indonesian and international pharmaceutical regulations.
- Review and advise on regulatory submissions for drug product approvals.
- Engage with regulatory authorities, such as BPOM, on behalf of the company.
- Ensure compliance with regulations related to pharmaceutical marketing, advertising, and promotion.
- Support the development and execution of regulatory strategies for product launches.
- Advise on post-market surveillance requirements and pharmacovigilance.
- Assist with intellectual property matters related to pharmaceutical products.
- Monitor changes in pharmaceutical laws and regulations and assess their impact.
- Draft and review legal documents and agreements related to regulatory affairs.
- Collaborate with R&D, clinical, and commercial teams on regulatory matters.
Qualifications:
- Juris Doctor (J.D.) or equivalent law degree from an accredited institution.
- Admission to the Indonesian Bar (PERADI) is required.
- Minimum of 6 years of experience in pharmaceutical regulatory law.
- In-depth knowledge of Indonesian pharmaceutical regulations (e.g., BPOM guidelines).
- Experience with international pharmaceutical regulations (e.g., FDA, EMA) is a plus.
- Strong understanding of intellectual property law as applied to pharmaceuticals.
- Excellent legal research, analytical, and problem-solving skills.
- Exceptional written and verbal communication skills.
- Ability to work independently and manage multiple projects in a remote environment.
- Proven ability to collaborate effectively with cross-functional teams.
- High degree of professionalism and attention to detail.
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