Regulatory Affairs Manager

Job Description

• Prepare plan and set up process for filing new medicine applications and maintenance

of registration of existing company's products with regulatory authorities in timeline required.

• Notify regulatory authorities of changes to medicines.

• Maintain the process for update label based on requirement of Global for products

responsible the monitoring of packaging and labeling.

• Assist in the monitoring of PV system if any.

• Assist for Product quality control together with SCM Team if any.

• Obtain regulatory approval within optimum timelines and subsequently ensure new

products are made accessible in the fastest time possible.

• Ensure immediate regulatory authority notification in relation to medicine changes.

• Help to maintain high quality and accurate packaging and labelling of company's products.

• Develop and implement time and cost saving initiatives for this role.

• Develop and implement services to assist in delivering better value to customers.

• Specific measures as per personal performance grid.

• Good collaboration with other function team for supporting business.

• University graduate major in medicine/pharmacy

• Prior experience in the pharmaceutical industry at least 3 years .

• Familiar with policies and procedures of Ministry of Health.

• Good working knowledge of applicable Laws and Regulations.

• Relevant knowledge of the health industry.

• Relevant knowledge of products and options.

• Competent in English language.

Current Employees apply HERE

Current Contingent Workers apply HERE