Senior Clinical Trial Regulatory Affairs Expert

<h3>The Position</h3><p>We are looking for you to join Roche and our Roche Services &amp; Solutions Center in Budapest.</p><p></p><p></p><p>Roche is a global healthcare company offering exceptional career paths and great benefits for fresh graduates and outstanding professionals. We are continuously expanding, looking for new talents to join our transforming Services &amp; Solutions Center. We offer a flexible working framework (1 office day/week on average) and provide fully remote working conditions within Hungary.</p><p></p><p>What we do:</p><p>The Clinical Trial Regulatory Management Team (part of Product Development Regulatory Operations) enables the development of organizational and people capabilities of the future, we support and optimize the delivery of projects and initiatives to the organization both on the molecule and molecule-enabling portfolio.</p><p>We are responsible for enabling the future of clinical trials from a regulatory perspective by pushing boundaries to deliver medical solutions now in order to transform patients’ lives.</p><p></p><p>Your day to day responsibilities are:</p><p>As a Senior Clinical Trial Regulatory Affairs Expert (Sr. CTRAE) within Roche Service &amp; Solutions Center in Budapest, you will enable the Regulatory function to deliver data and insights about our medicines. The Sr. CTRAE engages across research and early development (RED), affiliates and all product development functions to develop and realize strategy and deliver fit-for-purpose solutions to achieve Regulatory, Product Development and Roche vision.</p><p>The role sits in a dynamic and multifaceted environment and requires strong global clinical trial regulatory knowledge and an innovative and experimental mindset and willingness to push the boundaries and norms to get patients faster access to treatments.</p><p></p><p>As a qualified expert, you:</p><ul><li><p>Provide expert advice and regulatory insights to EU and International Regulatory Managers on external and internal requirements for clinical trial applications (CTAs) and monitor the regulatory landscape for changes</p></li><li><p>Engage in dialogue with health authorities to ensure efficient approvals of submissions</p></li><li><p>Represent the Clinical Trial activity on regulatory and study management teams</p></li><li><p>Cross functional (including CROs) coordination and collaboration to plan, compile, dispatch and track submissions and approvals of core CTAs or common documents and amendments, using the appropriate systems</p></li><li><p>Participate in projects and initiatives outside of the core scope of Clinical Trial Regulatory Management responsibilities</p></li><li><p>Influence global policy in matters regarding clinical trials</p></li><li><p>Support the learning and development of yourself and other team members</p></li><li><p>Identify and pursue opportunities for streamlining and automating CTA processes.</p></li></ul><p></p><p>What can you bring to our team: ​</p><p>We are looking for someone who is keen to develop regulatory insights through his or her experience, regulatory and scientific knowledge to determine solutions and solve complex problems. As an ideal team member, you are able to influence individuals or groups on more than one level who may have different interests or goals to reach consensus and achieve team objectives.  Furthermore, you have:</p><ul><li><p>BS/BA degree and/or minimum 5 years relevant experience in pharmaceutical industry or CRO</p></li><li><p>At least 3 years of experience working on CTA activities/regulatory submissions/country specific requirements, processes and documents from a global regulatory perspective (e.g. EU, ROW, USA)</p></li><li><p>In-depth knowledge of pharmaceutical/biotechnology internal guidance documents and Standard Operating Procedures (SOPs) dealing with EU and ROW clinical trial requirements</p></li><li><p>Strong teamwork and collaboration skills</p></li><li><p>Strong communication, influencing and negotiation skills</p></li><li><p>Ability to assess priorities and set strategies to align with/meet business needs</p></li><li><p>Conflict management &amp; problem solving skills</p></li><li><p>Flexibility/adaptability on overarching process changes</p></li><li><p>Fluent in written and spoken English.</p></li></ul><p></p><p>In exchange we provide you with:</p><ul><li><p>Development opportunities: Roche is rich in learning resources. We provide constant development opportunities, free language courses &amp; trainings, the possibility of international assignments, internal position changes and the chance to shape your own career.</p></li><li><p>Excellent benefits &amp; flexibility: competitive salary and cafeteria package, annual bonus, Private Medical Services, Employee Assistance Program, All You Can Move Sportpass, coaching / mentoring opportunity, buddy program, team buildings, holiday party. We also ensure flexibility, to help you find your balance: home office is a common practice, a