Job Summary
Execute 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
- Implement regulatory affairs policies procedures and standards to ensure alignment to global DKSH quality policy and local/international quality standards
- Maintain marketing authorization of products and licenses to operate/ permits of DKSH Healthcare Business Unit
- Perform regulatory affairs activities for DKSH Healthcare Business Unit clients
- Coordinate development activities focusing on regulatory compliance such as audits
- 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
- Support superior in managing day-to-day operating expenditures against operating budgets to ensure efficient usage of resources
Functional Skills and Knowledge
- Demonstrate good knowledge on regulatory affairs tools concepts and methodologies
- Demonstrate good working knowledge comprehension and applications of local regulations
- 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
Bachelor of Science in Pharmacy Licensed by Philippines Regulations Commission
Required Experience:
Junior IC
Job Summary Execute 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 regulationsGeneral Responsibilities Implement regulatory affairs policies procedures and st...
Job Summary
Execute 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
- Implement regulatory affairs policies procedures and standards to ensure alignment to global DKSH quality policy and local/international quality standards
- Maintain marketing authorization of products and licenses to operate/ permits of DKSH Healthcare Business Unit
- Perform regulatory affairs activities for DKSH Healthcare Business Unit clients
- Coordinate development activities focusing on regulatory compliance such as audits
- 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
- Support superior in managing day-to-day operating expenditures against operating budgets to ensure efficient usage of resources
Functional Skills and Knowledge
- Demonstrate good knowledge on regulatory affairs tools concepts and methodologies
- Demonstrate good working knowledge comprehension and applications of local regulations
- 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
Bachelor of Science in Pharmacy Licensed by Philippines Regulations Commission
Required Experience:
Junior IC
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