• 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.

[자격요건]

경력사항: 경력(5년 이상 )
학력사항: 대학교(4년)졸업
직무기술: Regulatory Affairs

[우대사항]

전공계열: 의/약학 계열