Senior Regulatory Start Up Associate

 About the Role

The RSA 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. Strong planning and alignment skills ensure activities are structured and adaptable to change. Success depends on effective collaboration, building trust and working cross-functionally, while persuasion skills help influence decisions and drive outcomes. A commitment to self-development is key to staying current in a dynamic regulatory landscape.

Responsibilities

• 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.
• 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..

Experience and Qualifications

• 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. 

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. 

Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. 

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.