Regulatory Affairs Specialists assist in obtaining and maintaining government approval for drugs, medical devices, nutritional products, and related materials. They are often employed by pharmaceutical, biotechnology, and medical device companies. They may also work in government or law.
- Approval announcement to related departments
- Regulatory document filing
- Maintain/updating regulatory database
- HRA budget control (monthly review & report HRA budget utilization)
- Support other related dept. by provide MA certificate (NIE) and or related approval for requirement of e-catalogue, hospital standardization, audit, etc.
- Other HRA administration tasks
- Minimum D3 or S1 from any major, Secretary or Business Administration is preferred
- Experience: minimum 1 - 2 years experiences as administration staff
- Strong communication both verbal & written, collaboration & interpersonal skills
- Detailed & able to organize all her tasks
- Multitasking & agile
- Good teamwork
- Strong working knowledge with Microsoft office, Excel, Power point, etc.
- Intermediate in English both written & spoken
- Understand business & financial environment
- administrative support
- regulatory requirements