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Regulatory operation
Job Description
- Liaise with government to ensure regulatory compliances
- Establish and maintain positive relationships & strong collaboration with government agencies and other regulatory authorities
- Lead the preparation of new regulatory documents, registration & applications to enable product registration including new, renewal, variations, special import license, promotional materials, etc.
- Planning, undertaking and overseeing product trials and regulatory inspections.
- Proactively provide analyzing regulatory issues and communicate/ improve effectively with key stakeholders in order to contribute development of strategies to mitigate to deliver robust actions
- Ensure high level of knowledge on the science of products within defined portfolio are timely updated
- Provide advice, train other company stakeholders as required to build knowledge about company policies, practices and systems and compliant utilization.
- Planning and manage budget efficiency.
- Maintain required regulatory compliance databases, systems and processes.
- Collaborative working together with other related functions to deliver operational tasks. Ensure that quality standards are met and submissions meet strict deadlines
- Organize, gather, evaluate, manage and collate information & Ensure compliance with regulations.
- Keep up to date with changes in regulatory legislation and guidelines. Highlight and propose mitigation plan in advance to minimize business impact.
- Analyze complicated information/ projects, including trial phase & propose the whole plan
- Outline requirements for labelling, storage and packaging.
- Liaising and negotiating with regulatory authorities. Keep track of registration status, submissions and registration timeline.
- Providing advice about regulations to stakeholders.
- Build and develop RA team.