Associate Manager Regulatory Operations - US

Overview Associate Regulatory Operations Manager is primarily responsible for planning, driving and coordinating operational aspects of regulatory and start-up across a region, by partnering with the Project Manager to ensure project deliverables are met within agreed timelines and in accordance with client expectations. This role is suitable for individuals who are new to the role of Project Manager or Regulatory Operations Manager or other leadership roles within the CRO industry. Essential training in customer service, project management skills and regulatory and start-up technical skills will be provided at commencement of the position. Responsibilities Define a Regulatory Start Up (RSU) strategy and prepare an RSU management plan. Oversee the execution of regulatory start up for assigned projects in accordance with the agreed RSU strategy. Ensure collaboration with local regulatory start up teams to deliver the agreed project scope in compliance with the RSU management plan. Oversee customization of core start-up documents to local requirements. Ensure preparation and distribution of core contract and budget templates to applicable team members. Oversee submission processes to health authorities, ethics committees and other review bodies. Provide regional coordination for meeting approval timelines. Oversee site activation package compilation and approvals. Proactively identify risks to start up and escalate to the Project Manager. Develop RSU mitigation plans. Provide timely updates of regulatory start up progress to the Project Manager. Present at external and internal meetings including project internal and external meetings and kick-off meetings. Serve as a client contact for regulatory start up related items. Support business development by providing relevant information on regulatory start-up and attending Bid Defenses to present Novotech's regional capabilities. Ensure accurate completion and maintenance of internal systems including CTMS, relevant databases, and tracking tools. Deliver presentations/training to clients and internal/external stakeholders regarding regulatory start up activities. Facilitate cooperation between cross-functional teams. Contribute to the collection, interpretation, analysis, and dissemination of accurate regulatory intelligence. Identify areas of inefficiency in regulatory start up processes and make recommendations for improvements. Represent Novotech at industry fora (conferences, professional associations, committee work, international investigator meetings). Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company. Work with assistance from the Line Manager and guidance from a functional mentor to deliver start-up of projects as outlined in the core responsibilities of this document. Primarily manages single country or small-sized projects. Minimum Qualifications & Experience Graduate in a clinical, pharmacy or life sciences related field. At least 5 years' experience from a CRO, biotech, or the pharmaceutical industry. Activities related to trial start-up and/or regulatory operations. Thorough knowledge of applicable regulations. Able to manage in a matrix environment. Confident decision-making and problem-solving. Strong presentation, documentation, and people skills. High proficiency in English. The salary range for this position is $110,000 - 145,000 based upon experience. 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, and 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 in 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 contacting you regarding your application. #J-18808-Ljbffr