- Maintaining, managing and improving GMP facility with the help of senior GMP consultant;
- Ensuring compliance with regulations set by the Authorities
- Providing advice about regulations to manufacture team
- Planning, undertaking and overseeing product development and regulatory inspections
- Keeping up to date with changes in regulatory legislation and guidelines
- Offering advice about company policies, practices and systems
- Obtaining marketing permission
- Liaising and negotiating with US and international regulatory authorities
- Ensuring that quality standards are met and submissions meet strict deadlines
- Preparing documentations
- Relevant degree such as biotechnology, biomedical science et al.
- Good communication skills
- Good interpersonal skills
- Excellent language skills
- Related work experiences preferred.