Regulatory Specialist

1 week ago

Singapore Emprego SG Full time

**Salary**: up to $5500

**Duration**: 1 year contractWorking Days & Hours: Mon-Fri Office HoursLocation: Tuas
- Manage a portfolio of CTAs including preparation and distribution of documentation associated with new initial CTAs and all CTA maintenance activities such as substantial amendments, end of trial notifications etc.
- Provide advice on submission strategy, country requirements, etc. as well as operational support for Regulatory submission preparation and processing of amendments.
- Review of and input on documents related to clinical trial submissions managed by other stakeholders such as IB, Protocols.
- Ensure approved company CTA processes are followed within agreed timelines.
- Monitor key project milestones (actual vs. planned activities and timelines) and identify and communicate issues/changes to assigned stakeholders and management as agreed in company procedures.
- Support inspection readiness activities when applicable
- Review and maintain awareness of regulatory intelligence relating to clinical trials and advise stakeholders accordingly.
- Ensure all relevant databases and activity trackers are populated within agreed timelines and compliance/reporting requirements met, and provide operational support for Regulatory and/or non-Regulatory systems that are critical for Regulatory submission and maintenance activities.
- Provide technical support on document preparation e.g. Excel spreadsheets, Power Point presentations.
- Undertake all necessary training in order to achieve compliance with internal/external processes
- Provide operational support for the CTS Team as required.
- Comply with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives
- This position reports to the Manager, CTS

**Job Requirements**: Degree in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences

4 Year Degree

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