Senior Regulatory Affair Executive

DKSH Group; Daerah Khusus Ibukota Jakarta; On-site; USD 40.000 - 60.000; Full time

Job summary

A global business firm is seeking a Senior Regulatory Affair Executive in Jakarta. Responsibilities include supervising quality assurance and regulatory compliance, coordinating audits, and providing training for staff. Ideal candidates should have a diploma in relevant fields and strong knowledge of local regulations. This full-time position is vital for maintaining company standards in safety and health.

Qualifications

• Proven experience in regulatory compliance and quality assurance.
• Ability to design quality management systems.
• Experience in training interventions for quality standards.

Responsibilities

• Supervise execution of QA and regulatory policies.
• Support management of operating expenditures.
• Coordinate quality development activities focusing on compliance.

Skills

Quality assurance tools knowledge

Dangerous Goods Regulations understanding

Local regulations applications

Office productivity tools (Excel, Word, PowerPoint)

Fluency in local language and English

Education

Diploma/certification in Science, Chemistry, Pharma

Job description

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Title: Senior Regulatory Affair Executive

Location:

Jakarta, ID, ID

Global Business Unit: HEC

Job Function: Regulatory Services

Requisition Number: 190729

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 regulations

General Responsibilities

• Support superior in managing day-to-day operating expenditures against operating budgets to ensure efficient usage of resources
• Supervise the implementation of regulatory affairs' policies, procedures and standards to ensure alignment to global DKSH quality policy and local/international quality standards
• Design quality management systems, include data management, quality criteria/checklists, supporting tools and techniques
• Conduct investigations of non-conforming regulatory affairs activities, including identifying underlying causes, and suggesting corrective actions
• Provide constructive recommendations to enhance policies, practices and processes related to quality assurance (QA), safety, health & environmental (SHE) and registration (REG)
• Identify training needs - quality assurance (QA), safety, health & environment (SHE) and registration (REG) - and organize training interventions to meet quality standards
• Coordinate quality development activities focusing on regulatory compliance such as audits, quality management reviews, and trainings
• Provide technical assistance to internal stakeholders on regulatory affairs related issues, and trouble shooting when necessary
• Liaise with internal and external stakeholders (i.e. government bodies) on regulatory affairs related queries, laws and regulations

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 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 local language and ideally in English, both written and spoken

Education

Diploma/certification of Science, Chemistry, Pharma or related disciplines

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How to contact us

If you have any questions regarding our privacy practices or how we handle your data, please contact our privacy team and Data Protection Officer by sending an email [e-mail] by completing the form available https://www.dksh.com/global-en/data-request-form?dksh_contact=1578343480793

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SAP as service provider

Lifespan: Session

Provider

Description

Enabled

dksh.com

Lifespan:1 year 1 month

Description:Performance/Analytics

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Lifespan: Session

Description:Other/Third party

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