Regional Regulatory Affairs Manager
A leading medical company in healthcare is seeking an enthusiastic Regional Regulatory Affairs Manager to be part of their team in Singapore.
- Successful registration of new products.
- Regulatory input to strategic decision-making including portfolio review, prioritization, and external communications.
- Prepare, submit and support clinical trial applications including all related safety activities.
- Manage and oversee all relevant maintenance activities including LifeCycle Management strategy
- Develop and maintain operating procedures or local and regional working practices.
- Maintain current knowledge of relevant regulations, including proposed and final regulations in the region.
- Maintain good work relationships with regulatory authorities in the region and seek to influence appropriately
Skills and Requirements
- Minimum of 5 years prescription regulatory affairs experience
- Licensed Pharmacist preferred
- Ability to operate across a wide range of business activities and projects, including in-licencing and out-licencing projects