Regulatory Start Up Associate II

About The Role

The Regulatory Start Up Associate is primarily responsible for planning, preparation, review of country and site level ethics and regulatory authority applications and submissions during project start-up, in compliance with ICH-GCP and local regulatory requirements, to ensure timely clinical trial approval.

Responsibilities

• Serve as the primary point of contact for the Regulatory Start Up Manager (RSM) and/or Project Manager (PM) during start-up on allocated projects.
• Provide expertise and guidance to RSM and/or 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.

Experience And Qualifications

• 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.
• Responsible for quality start-up deliverables at the country and site level; follows project requirements and applicable country rules, with moderate oversight from the RSM or PM.

Salary Band - $70,000 - 95,000USD – Salary offered will be based on candidates experience level.

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. 

We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech.

Novotech is a global full-service clinical Contract Research Organization (CRO).

Headquartered in Sydney, Australia, Novotech has 34 offices across Asia-Pacific, North America, and Europe. Novotech employs over 3000 employees and has over 5000 site partnerships and the resources and infrastructure to scale regionally and globally as clinical programs advance.

Novotech provides clinical development services across all clinical trial phases and therapeutic areas including feasibility assessments, ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.