Title:  Assistant Regulatory Affairs

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