Associate Manager, Regulatory Affairs

6 days ago

Singapore LOTUS INTERNATIONAL PTE. LTD. Full time

The individual Contributor will be based in the Singapore office and is responsible for working with Global Regulatory Teams and head office-based team members (e.g. Business Development Team) to define and implement country-specific regulatory strategy for assigned products. This incumbent will report remotely to the Distribution Regulatory Affairs Director.

**Responsibilities**:

- Provides direction for the activities related with assigned products. Works with Global Regulatory Teams (GRT)and head office-based team members (e.g. Business Development Team) and to define and implement the regional and local strategy for assigned products.
- Understands regional and local requirements and advises the Global Regulatory Team (GRT) on applicable regulatory requirements, guidelines and processes, region-specific regulatory issues with impact on the product strategy or deliverables. Keeps up to date on understanding of regional/regulatory environment.
- Provides inputs to submission tactical planning and timelines including lifecycle submissions (labeling changes, renewals, and safety reports).
- Responsible for communicating with the cross functional team and all the regulatory submission for Singapore and market extension projects and assuring that all the Questionnaire request, Audit Dossier request, DD response and submission dossier request has been submitted on the time.
- Ensure internal regulatory database/ system is properly updated and maintained.
- Ensure that all deficiency letters and client’s questions are properly and timely replied to have approved per the company goal.
- To provide regulatory pathway and resolve regulatory related queries to the cross functional department.
- Responsible for review and drafting of license agreement (regulatory aspect)
- Responsible for Pharmacovigilance in Singapore
- Manages regulatory interactions with Singapore Health Authority
- Provides support to Regulatory Affairs Heads to develop metrics for the region.

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