ASSOCIATE DIRECTOR OF TRANSLATIONAL REGULATORY SCIENCE
Descripción de la oferta de empleo
Barcelona (on-site) Within Oncology Regulatory Science, Strategy & Excellence (ORSSE), we bring hope and solutions to patients across the globe.
As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients.
We work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible.
The Associate Director of Translational Regulatory Science provides strategic and regulatory leadership to the development, commercialization, and life cycle management of assigned product(s) with a specific focus on translational areas.
Translational areas are development opportunities that take place in cross-functional teams and focus on biomarkers or approaches such as the development of novel therapeutics, endpoints, in vitro diagnostics (IVDs), regulatory innovations, or the introduction of digital therapeutics in development programs.
This requires early anticipation of the potential regulatory impact and developing capabilities to design regulatory strategies applicable to early and late development projects, which meet regulatory agencies’ requirements.
The Associate Director of Translational Regulatory Science interfaces between the functional areas involved in these projects, participates in the projects as a team member, and helps identify all necessary regulatory aspects that may benefit from interactions with regulatory authorities in both early and late stages of development or through an ongoing development program.
The Associate Director of Translational Regulatory Science plays a key role in working closely with the Regulatory Affairs Directors (RADs) assigned to development programs and contributes to product development by organizing regulatory authority interactions dedicated to focused topics to be an integral part of a development program.
In this role, you will be responsible for developing, aligning, and implementing regulatory strategies to ensure successful early and late Oncology development projects on a global scale.
The successful candidate will work closely within cross-functional teams to ensure that regulatory requirements in Oncology clinical trials, including those for innovative biomarkers, technologies (e.
., ctDNA, computational pathology, AI/ML), and therapeutics are met throughout the drug development process.
The impact and visibility of this position are high, with implications for regulatory decisions, timelines, and advancement for the company in contributing to the ORSSE
Detalles de la oferta
- Assoc Princ Specialist Reg Drug Proj Del
- Sin especificar
- 02/10/2024
- 31/12/2024
This is a recognition of the institute’s commitment to developing an hr strategy for researchers, designed to bring the practices and procedures in line with the principles of the european charter for researchers and the code of conduct for the recruitment of researchers (charter and code)......
Experience of working on large requirements i... solid financial skills along with the ability to process large amounts of information... requisitos del puestoresponisibility work closely within the organisation to determine cost effective solutions and provide on-time efficient customer quotes or pricing......
C2/mother tongue level of english... contribute to students’ end of term reports in line with school policy... otros datos del puesto subject teacher repsonsibilities: assist in the planning, preparing and delivering of departmental schemes of work in accordance with the national curriculum and with......
Our client is one of the biggest b2b it and telecommunication hardware resellers in europe, with more than 20 years of experience... responsibilities as a sales representative your key responsibilities of this role include: - sales via customer enquiries and following up leads - answering clients request......
Join us in shaping the future of real estate sales!... position: head of sales department key responsibilities: lead and manage the sales team, ensuring they meet and exceed sales targets develop and implement sales strategies to drive business growth collaborate with marketing and other departments......
Multinational company is seeking an order management associate... good knowledge of office pack and most usual erp... basic knowledge of accounting skills: fluent in english and spanish... maintain a strong relationship with the rest of the ali teams in europe and us... the g&a; department of a multinational......
Showing them the benefits of build a partnership with the company... requisitos del puestoyou are the ideal candidate if:- you are fluent in german and have an advanced level of english... do you want to work in an international and modern environment? if you have experience in sales and want to be part......
El director de arte estará a cargo de definir el estilo visual del varios videos para una marca de bebidas... descripción buscamos director de arte para grabación de videos para redes sociales de coctelería y estilo de vida sobre el puesto es un trabajo puntual a ser grabado en málaga los días 11,12......
Buscamos director inmobiliario y comerciales inmobiliarios para incorporar al equipo de nuestra oficina de chiclana de la frontera... si tienes experiencia, ganas de trabajar y de desarrollarte laboralmente ahora es tu momento puedes unirte a nuestro grupo... además en el puesto de comercial, se valora......
Confidencial cuenta con una posición como director de marketing para crear estrategias innovadoras y efectivas para posicionar la marca, aumentar la visibilidad y generar demanda de los productos o servicios de la empresa... analizar el mercado y la competencia para identificar oportunidades de crecimiento......