Regulatory Start Up Manager

2 weeks ago

Canberra, Australia Novotech Asia Full time

Minimum Qualifications & Experience:

- Graduate in a clinical, pharmacy or life sciences related field.
- At least 5 years' experience from a CRO or the pharmaceutical industry in activities related to trial start-up and/or regulatory operations
- Through knowledge of applicable regulations
- Able to manage in a matrix environment
- Confident decision-making and problem-solving
- Competent working in virtual teams across time zones
- Strong presentation, documentation, and interpersonal skills
- High proficiency in English

**Responsibilities**:

- Define a Regulatory Start-Up (RSU) strategy and prepare a RSU management plan
- Oversee the execution of regulatory start-up for assigned projects in accordance with agreed RSU strategy.
- Ensure collaboration with local regulatory start-up teams to successfully deliver the agreed project scope in compliance with the RSU management plan.
- Distribute start-up related documents to local regulatory start-up teams
- Oversee customization of core start-up documents to local requirements
- Ensure preparation and distribution of core contract and budget templates to applicable team members.
- Oversee submission processes to health authorities, ethics committees and other review bodies. Provide regional coordination for meeting approval timelines
- Oversee site activation package compilation and approvals
- Proactively identify any risks to start-up and escalate to Project Manager. Develop RSU mitigation plans.
- Provide timely update of regulatory start-up progress to Project Manager
- Present at external and internal meetings including but not limited to: project internal and external meetings, kick-off meetings.
- Serve as a client's contact for regulatory start-up related items
- Support business development by providing relevant information on regulatory start-up and attending Bid Defences to present Novotech's regional capabilities
- Ensure accurate completion and maintenance of internal systems including CTMS, relevant databases, and tracking tools,
- Deliver presentation/training to clients and internal/external stakeholders regarding regulatory start-up activities
- Facilitate cooperation between cross-functional teams
- Contribute to the collection, interpretation, analysis, and dissemination of accurate regulatory intelligence
- Identify areas of inefficiency in regulatory start-up process and make recommendation for improvements.
- Represent Novotech at Industry fora (conferences, professional association, committee work, international investigator meetings).
- Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company.

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