Regulatory Start Up Associate II - Taiwan

The Regulatory Start-Up Associate (RSA) and Regulatory Start-Up Lead (RSL) are responsible for the planning, preparation, and review of country- and site-level ethics and regulatory authority submissions during the start-up phase of clinical trials, and, where applicable, throughout maintenance and close-out. They ensure that all submissions comply with ICH-GCP guidelines and local regulatory requirements to support timely trial approvals.
The RSA / RSL has an action-oriented mindset to proactively address challenges and advance start-up activities. The ability to balance stakeholders is essential, considering ethical, cultural, and organizational needs.

Serve as the primary point of contact for the Regulatory Start Up Manager (RSM) and/or Project Manager (PM) and/or sites for country and site level start up activities on allocated projects.

• Provide expertise and guidance to RSM/PM on country and local regulations and practices, keeping abreast of developments and changes in regulations, guidelines and practices surrounding clinical trial approvals in relevant countries.
• Work within the scope of the Regulatory Start Up plan or other applicable project plan, relevant SOPs, and ICH-GCP.
• Provide country and site level information on submission deadlines and timeline metrics for local Regulatory Authority, Ethics Committees, Investigational Review Boards and other local bodies as appropriate.
• Works within forecasted submission/approval timelines and ensures they are complied with, updating appropriate systems accurately and in a timely manner, including planned and actual dates of submissions/approvals.
• May serve as a point of contact with investigative sites for Regulatory Authority, Ethics Committees/Review Boards and other local authority related activities.
• Prepare and submits Central EC/IRB applications, local EC/Governance applications, Regulatory Authority applications, and other local regulatory authorities or site submissions as required. 
• Ensure submission packages are accurate and complete per local requirements.
• Review and follow-up on comments/questions raised by reviewing bodies and advise/contribute to response. Submit response with Client approval within timeframe.
• Follow submission, application to approval.
• May prepare and submit ongoing amendments, notifications, safety reports and study related materials required by Regulatory Authorities, Ethics Committees/Review Boards and other local authorities as per local requirements.
• Perform country and site Informed Consent Form (ICF) customisation in line with local requirements.
• Initiate translation of submission documents as applicable and review translated documents before submission.
• Support Clinical Contracts Specialists (CCS) to review and finalise the Country Master budget.
• Adapt site budgets from Country Master budgets and coordinate site budgets and Clinical Trial Agreement (CTA) negotiations with sites and/or CCS for finalisation and approval from PM/RSM and client if required.
• Review and approve proposed packaging and labelling for clinical trial material.
• Prepare and submits import/export license applications and management of licenses and custom clearance thereafter if required.
• Register project onto an official clinical trial registry as agreed to with Client and update status as required.
• Submit regulatory and ethics documents and relevant study correspondence to the trial master file and ensures accuracy and completeness of these documents. 
• Serve as an independent essential document reviewer.
• Escalates issues to RSM/PM that may delay or impact project start up timelines and deliverables; provides rationale for delays and contingency plan to mitigate impact.
• Ensure all clinical trial management systems are current and up to date at all times with all relevant trial data. 
• Understand the responsibilities of Novotech as a service provider in the pharmaceutical and biotech industry and ensure all communications with external and internal customers present a positive professional image of the company. 

• Undertake additional responsibilities assigned by your Line Manager.

  RSA I

• Entry level,  0 - 1 years Regulatory Start Up or related experience in clinical trial industry. 
• RSA I will learn the company culture, policies and procedures for regulatory and start up activities through specialised training; and on the job training by supporting the day-to-day start-up activities of clinical projects and project team members such as RSAs/RSL, PMs, RSMs.

• Responsible for quality start up management and deliverables at the country and site level; follows project requirements and applicable country rules, with close supervision from the LM and oversight from RSM/PM. 

  RSA II

• At least 1-3 years Regulatory Start Up experience in clinical industry or equivalent experience in other roles in the Clinical industry.
• Competent and productive and can perform a wide range of responsibilities within the Regulatory Start-Up function.
• Works independently with general supervision.
• Responsible for quality start-up deliverables at the country and site level; follows project requirements and applicable country rules, with minimal oversight from the RSM or PM.

• Provide mentorship to junior staff. 

  Senior RSA

• At least 3-5 years of Regulatory Start Up experience in clinical industry.
• Fully competent and productive and can perform the full range of responsibilities within the Regulatory Start-Up function.
• Works with a high degree of autonomy.
• Participate in company start-up initiatives, contributing to development and maintenance of Regulatory Start Up processes, tools and SOPs. Identify areas of inefficiency in process and make recommendations for improvements.
• Assist with RSA training in the development and delivery of training in conjunction with Learning and Development Manager and serve as a mentor to junior RSAs.

• Serve as the local subject matter expert on specialised aspects of regulatory and start up activities.Where applicable, may act as a RSA Country Lead for projects with no RSM.

  Regulatory Start Up Lead (RSL)

• 5 years plus experience in a Regulatory Start Up role in the clinical trial industry.
• Comprehensive, specialised knowledge within the field of work, able to use the knowledge to solve problems, and make judgements within own scope of work.
• Functions as a member of cross-functional/cross-country working teams, especially with Project Management and Clinical Operations teams in assigned countries.
• Acts as regional/multi-country regulatory lead, coordinates local teams across sub-regions, and collaborates with Project Manager and/or Regulatory Start Up Manager to ensure strategic priorities are understood and implemented. 
• Ensures that start-up activities are undertaken in accordance with agreed timelines, allocated budgets, required quality standards and company policies and procedures.
• May participate in bid defence meetings and/or support proposals with ethics/regulatory intelligence and start up strategies and timelines.
• Subject Matter Expert on local and/or regional ethics/regulatory processes and requirements or specific start-up task(s).
• Lead or participate in initiatives to drive overall performance improvement, quality and customer experience.
• May participate in vendor Audits including presenting on Novotech Regulatory Start Up SOPs and processes.

Serve mentor to junior team members and as a back-up line manager.

• Graduate in a clinical, pharmacy or life sciences related field.
• At least 1-2 years of related experience in either a CRO, pharmaceutical or clinical/hospital environment.