Senior Manager, Regulatory Affairs

📋 Description

• • BeiGene, Ltd. is seeking a highly motivated and experienced Senior Manager of Regulatory Affairs to join our rapidly growing team. This pivotal role is responsible for the comprehensive management, evaluation, and successful completion of regulatory projects, ensuring alignment with the company's overarching goals. The ideal candidate will possess a deep understanding of regulatory landscapes and a passion for contributing to the fight against cancer.
• • As a Senior Manager, you will be instrumental in the timely planning and meticulous coordination of all regulatory submissions. You will serve as a key advisor, providing expert guidance to cross-functional teams on optimal regulatory strategies and tactical execution. Your role will involve representing the Regulatory Affairs department on various project teams, contributing critical insights, and taking the lead in authoring and preparing essential annual reports and other regulatory documentation.
• • A core responsibility will be the end-to-end management of regulatory submissions, from initial preparation and assembly to review and final submission. This includes ensuring all submissions adhere strictly to current regulatory requirements and maintaining compliance throughout the product lifecycle.
• • You will proactively plan and manage a diverse range of regulatory activities for assigned projects, encompassing clinical, non-clinical, and Chemistry, Manufacturing, and Controls (CMC) aspects. This requires a high degree of autonomy and minimal supervision, demonstrating your ability to drive projects forward effectively.
• • A significant part of your role will involve assisting in the development and implementation of robust strategies aimed at achieving the earliest possible approvals and clearances for regulatory submissions. This necessitates a forward-thinking approach and a keen understanding of regulatory pathways.
• • You will be responsible for the meticulous preparation, including authoring where necessary, assembly, thorough review, and timely submission of all required regulatory dossiers. This applies to both the investigational phases and the registration of products in the United States and internationally.
• • Ensuring the ongoing compliance of all regulatory submissions with evolving regulatory requirements is paramount. You will also play a crucial role in supporting and managing the preparation of meeting requests and briefing documents for regulatory agencies.
• • The management of the preparation, review, and submission of all components of regulatory submissions, such as Investigational New Drugs (INDs) and their amendments, Biologics License Applications (BLAs)/New Drug Applications (NDAs) and their supplements, annual reports, and safety reports, will be a key function.
• • Active participation on project teams is expected, where you will contribute your specialized expertise on regulatory matters, influencing project direction and ensuring regulatory considerations are integrated from the outset.
• • You will be tasked with developing and maintaining a current and comprehensive understanding of regulatory knowledge, proactively advising management on significant developments and their potential impact on the company's projects. This includes ensuring compliance with departmental requirements and maintaining the regulatory archive.
• • Collaboration with external regulatory consultants and Contract Research Organizations (CROs) will be necessary to leverage specialized expertise and ensure efficient project execution.
• • The role demands excellent oral and written communication skills, coupled with superior planning and organizational abilities. You must be detail-oriented, a proactive self-starter, and comfortable taking on broad responsibilities within an entrepreneurial, fast-paced, and dynamic small company environment. Your ability to embrace change and demonstrate an entrepreneurial mindset will be critical to success.
• • You will contribute to BeiGene's core values by fostering teamwork, providing and soliciting honest feedback, demonstrating self-awareness, acting inclusively, taking initiative, embracing continuous learning, and maintaining a results-oriented approach. Your analytical thinking and clarity in communication will be vital in navigating complex regulatory challenges and driving excellence in all endeavors.