Regulatory Affairs Executive

Job description

The Position

The Position
This is an excellent opportunity to join a market leader where you can truly make your mark. You will integrate within an experienced Regulatory Affairs team and be responsible for; ​

• Prepare & submit RDMY products via MDA's Medcast website for registration
• Manage & secure product registration
• Support Quality Management System including prepare SOP documentation and ensure effective implementation.
• Maintain and update Poison/ DAT/ Psychotropic Drugs listing with National Pharmaceutical Control Authority (NPRA), Ministry of Health, as per Customs Regulations
• Maintain Poison “A” license. Provide quarterly reports of DAT/ Psychotropic Drugs to DCA or when required
• Coordinate and manage Post Market reporting in accordance to regulatory requirements (together with Regulatory Affairs / Compliance Officer)
• Co-ordinate and perform Pre-market evaluation for all products including IVD Class A, B, C/ D products when required.
• Conduct business in full compliance to Behavior in Business and Behavior in Competition

Who you are
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
Ideally you are equipped with experience in the field of Regulatory Affairs within the medical diagnostics industry.

• Bachelors or Masters Degree in Health/Science/ Pharmacy discipline from a recognized University

• Similar experience/ similar capacity with a Multi-national company

• Marketing and business development experience will be a plus

• Proficient in English and Bahasa Malaysia.

• In-depth Product registration knowledge especially in In-Vitro Diagnostic evices

• Advanced MS Excel and/or MS Access skills for database/reports creation

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.