Senior Regulatory Start Up Associate

As a Senior Regulatory Start Up Associate at Novotech, your role will involve planning, preparing, and reviewing country and site level ethics and regulatory authority applications and submissions during project start-up. Your responsibilities will include: - Serving as the primary point of contact for the Regulatory Start-Up Manager (RSM) and/or Project Manager (PM) on allocated projects. - Providing expertise and guidance on country and local regulations, keeping abreast of developments and changes in regulations. - Working within the scope of relevant SOPs and ICH-GCP guidelines. - Providing country and site level information on submission deadlines and timeline metrics. - Ensuring compliance with submission/approval timelines and updating systems accurately. - Serving as a point of contact with investigative sites for regulatory and ethics-related activities. - Preparing and submitting various applications such as Central EC/IRB, local EC/Governance, and Regulatory Authority applications. - Reviewing and following up on comments/questions from reviewing bodies and submitting responses within timeframe. - Initiating translation of submission documents and reviewing translated documents. - Reviewing and approving proposed packaging and labeling for clinical trial material. - Submitting import/export license applications and managing licenses and custom clearance if required. - Registering projects on official clinical trial registries. - Submitting regulatory and ethics documents to the trial master file and ensuring completeness. - Participating in company start-up initiatives and contributing to the development of regulatory start-up processes. - Serving as a mentor to junior RSAs and participating in RSA training and development programs. - Acting as a local subject matter expert on specialized aspects of regulatory and start-up activities. Minimum Qualifications & Experience required for this role: - Graduate in a clinical, pharmacy, or life sciences related field. - At least 3-5 years of experience in a CRO, pharmaceutical, or clinical/hospital environment. At Novotech, you will be part of a supportive and inclusive work environment committed to gender equality and diversity. Flexible working options, paid parental leave, wellness programs, and ongoing development opportunities are some of the benefits provided. Novotech 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.,