Associate Manager, Regulatory Affairs, Singapore
4 days ago
**Job Description**:
- Provide technical leadership and manage submission pipelines in Singapore
- Provide regulatory input to strategic decision making; including portfolio review, prioritization, and external communications.
- Work with regulatory partners/vendors to obtain successful registration of new products.
- Support to prepare and manage relevant maintenance activities including LifeCycle Management strategy.
- Support in developing and maintaining standard operating procedures for local working practices.
- Maintain current knowledge of relevant regulations, including proposed and final regulations in the region.
- Manage activities such as audits, regulatory agency inspections, or product recalls in Singapore
Qualification Required:
- Pharmacy or Life Sciences qualification, or equivalent, with a minimum of 5 years prescription regulatory affairs experience especially in Singapore. Licensed Pharmacist preferred.
- Outstanding written and oral communication skills, with ability to influence others and negotiate successful outcomes
- Ability to operate across a wide range of business activities and projects, including in-licencing and out-licencing projects
- Proactive, quick learner and self-starter
- Comfortable working sometimes out-of-hours to liaise with international colleagues
- Project management skills
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