Regulatory Affairs Partner

Overview Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt. Die Position Roche Pharmaceuticals Who we are: At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity, and on seeing each other’s differences as an advantage. To innovate healthcare, Roche has ambitious plans to keep learning and growing – and is seeking people who have the same goals for themselves. At Roche we believe life is incredibly precious. So precious that we have recently embarked on a transformational journey so that we can deliver better outcomes to more patients faster. Our world is changing, our healthcare landscape is evolving and our portfolio is transforming - we are transforming. Imagine working for an organization which focuses on putting people at the heart of what they do. Where every single person within the organization is aligned to one main motivating force, that at the center of everything they do, and their number one priority; are patients. A place which gives every individual the autonomy and empowerment to make a difference, where you are not defined by a job title. Imagine waking up every morning feeling fulfilled, having purpose and meaning in your work. Regulatory Affairs Partner Purpose of the role: - Responsible for accelerating access to Roche innovations in line with overall strategic objectives that will enable value creation for patients at lesser cost to the society - Working with the wider team to translate the constantly evolving requirements of the Hong Kong, Macau and Greater Bay Area Regulatory environment into Roche policies, procedures, solutions and strategies that ensure compliance and maximize the value for patients. - Coordination and preparation of document packages for regulatory submissions from all areas of the Company. Compiles materials required in submissions, license renewals and regulatory related activities. Key Responsibilities: - Formulates and drives regulatory strategy for the responsible strategic and established products portfolio - Coordinates the collection of documents, records, reports and data from various departments for inclusion in regulatory documents. - Helps with the preparation of submissions for product approval including NCEs, import licenses to Macau and applications to the Greater Bay Area. - Contributes towards regulatory system shaping to foster a more patient-centric regulatory environment - Assists in the review of product labeling/advertising to ensure compliance with regulations. - Maintain procedures that ensures labeling compliance of products requiring secondary packaging - Keeps abreast of regulatory procedures and changes in industry practices. - Duties as assigned to support the License to Operate Team and the affiliate Who you are: Qualifications - >3 years of Hong Kong drug regulatory affairs experience in the capacity of a RA executive position or Associate RA manager; - Bachelor's degree or above in a Science related discipline; Capabilities - Regulatory Affair Partners are Roche’s primary contact with the HK Drug Office on regulatory matters, requiring the ability to work effectively cross functionally at a local level and with the global network as well as the capability to negotiate and influence externally. - Adaptable to change and entrepreneurial in nature in order to identify opportunities, while maintaining a laser focus on ensuring compliance and therefore playing a key role in retaining Roche Hong Kong and Macau’s License to Operate. - With broad and comprehensive expertise within the Regulatory environment you will lead foundation work and partner with the business to solve complex regulatory issues that impact the chapter and/or wider business. Contributes to development of squad/chapter based strategic plans and goals. Actively contributes to the learning & development of other chapter members in the License to Operate team. Mindset & Behaviors - Embrace the Roche Values of Integrity, Courage & Passion - Demonstrate Roche Leadership Commitment & Core Competencies - VACC - Embrace and master VACC (visionary, architect, coach, catalyst) behavior - Growth - Ability to learn and unlearn quickly, take risks and experiment, and contribute to the learning cycle by sharing knowledge with others inside and outside Roche - Value creation - Boldly act on key decisions and opportunities and boldly stop any activity that is not adding value. Ability to say “No” to stakeholders when the value is not predictable/foreseen - Digital - Be Innovative and drive digital transformation across organizations and industries to bring value and impact to the healthcare ecosystem - Enterprise - Think from an enterprise level, beyond boundaries and borders, to bring the best possible outcomes to both the local health environment, and more broadly, across Roche globally. - Enablers - - - Embrace agile ways of working to facilitate the transformation journey and achieve our North Star - Enabler mindset to leverage the internal and external networks to create value and scale impact - Self-managed - Self-management and self-direction - altruistic in supporting the global network to embrace PAM (Purpose. Autonomy and Mastery) Wer wir sind Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern. Gemeinsam können wir eine gesündere Zukunft gestalten. Roche ist ein Arbeitgeber, der die Chancengleichheit fördert. #J-18808-Ljbffr