Senior Regulatory Start Up Associate

As a Senior Regulatory Start-Up Associate at the company, your primary responsibility will be to plan, prepare, and review country and site level ethics and regulatory authority applications and submissions during project start-up. Your role is crucial in ensuring compliance with ICH-GCP and local regulatory requirements to facilitate timely clinical trial approval. Your key responsibilities will include: - Serving as the primary point of contact for the Regulatory Start-Up Manager (RSM) and/or Project Manager (PM) during start-up on allocated projects. - Providing expertise and guidance to RSM and/or PM on country and local regulations and practices, staying updated on developments and changes in regulations. - Working within the scope of the Regulatory Start-Up plan, relevant SOPs, and ICH-GCP guidelines. - Providing country and site level information on submission deadlines and timeline metrics for local Regulatory Authority, Ethics Committees, Investigational Review Boards, and other relevant bodies. - Ensuring submission packages are accurate and complete per local requirements. - Reviewing and following up on comments/questions raised by reviewing bodies and submitting responses within the timeframe. - Initiating translation of submission documents as applicable and reviewing translated documents before submission. - Participating in company start-up initiatives, contributing to the development and maintenance of regulatory start-up processes, tools, and SOPs. In addition to the key responsibilities, it is required that you have: - A graduate degree in a clinical, pharmacy, or life sciences related field. - At least 3-5 years of related experience in a CRO, pharmaceutical, or clinical/hospital environment. - At least 3-5 years of Regulatory Start-up experience in the clinical industry. The company, Novotech, is committed to providing a great workplace that promotes gender equality and inclusivity. They offer flexible working options, paid parental leave for both parents, wellness programs, and ongoing development programs. Novotech values diversity and encourages individuals passionate about clinical research and biotech, including those who identify as LGBTIQ+, have a disability, or have caring responsibilities, to apply. As a Circle Back Initiative Employer, Novotech commits to responding to every application and looks forward to contacting you regarding your application.,