Senior Manager, Regulatory Affairs Project Management

🕒 Março 19

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Apogee Therapeutics

SiteLinkedInTodas as Vagas

51 - 200 funcionários

🧬 Biotecnologia

💊 Farmacêutico

💰 $149.000.000 Series B em 2022-12

Biotechnology • Pharmaceuticals

Apogee Therapeutics é uma empresa de biotecnologia em fase clínica focada no desenvolvimento de novos biológicos para o tratamento de distúrbios inflamatórios e imunológicos. A empresa mira mercados principais em doenças inflamatórias e imunológicas como dermatite atópica, asma, doença pulmonar obstrutiva crônica, esofagite eosinofílica e outras condições relacionadas. A Apogee Therapeutics busca reformular o padrão atual de cuidados ao avançar terapias com anticorpos que visam mecanismos biológicos bem estabelecidos, com potencial para atender questões dermatológicas, respiratórias e gastroenterológicas. A empresa está comprometida em criar um ambiente de trabalho psicologicamente seguro enquanto prioriza opções de tratamento inovadoras para aqueles que vivem com essas condições.

Descrição

• This role blends regulatory expertise with advanced project management skills, developing complex plans to enable successful Regulatory submission activities and ensuring cross-functional integration across regions • Track and coordinate timelines and deliverables to support complex regulatory submission activities (IND/CTA/BLA/NDA/MAA) across multiple regions, as well as responses to queries and correspondence with subject matter experts • Work with the Regulatory team to translate strategic regulatory vision into actionable project plans, ensuring all cross-functional activities are coordinated and delivered on time • Organize and facilitate cross-functional meetings to coordinate, plan, and track submission activities, driving accountability and alignment among stakeholders worldwide • Monitor CTA/IND submission status across assigned projects • Support strategic planning and risk mitigation efforts related to regulatory activities, including portfolio level analyses that identify resource bottle necks across all programs and studies • Support evaluation, implementation, and use of project management tools (especially Smartsheet); define methodologies and reporting frameworks • Design and maintain Smartsheet sheets, reports, dashboards, and forms related to regulatory activities and ensure integration with program plans • Troubleshoot and enhance PMO solutions, support system updates and new capabilities • Demonstrate critical thinking and initiative to improve PM practices

🎯 Requisitos

• Bachelor’s degree in life sciences, pharmacy, chemistry, or related field • 5+ years of experience with at least 3+ years of project management experience in pharmaceutical or biotech industry is preferred • Experience with planning IND/CTA regulatory submissions required • Familiarity with components of regulatory submissions is required • Experience planning BLA/NDA/MAA submissions is required • Familiarity with CRO operations and global regulatory requirements for clinical trial applications • Experience supporting global interventional clinical studies and CTA submissions • Hands-on Smartsheet experience; Smartsheet Core Product Certification or equivalent desirable • Proficiency in project management tools (Smartsheet, ThinkCell, PowerPoint, Excel, SharePoint, Office Timeline Pro). Familiarity with regulatory systems (Veeva RIM) preferred • Knowledge of biotech processes, scientific terminology, drug development concepts • Proactive and structured approach to problem-solving, with ability to think cross-functionally and in multiple timeframes, and to distill into actionable plans/solutions • Strong organizational, communication, and problem-solving skills with the ability to manage multiple priorities and meet deadlines • Ability to work independently and thrive in a dynamic environment • Team player that contributes valuable ideas and feedback and can be counted on to meet commitments • Position requires up to 20% travel; this includes mandatory in person attendance to company All-Hands meetings held twice a year and frequent trips to Apogee offices in San Francisco and/or Boston

🏖️ Benefícios

• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless • Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly • Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits • We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave • Commitment to growing you professionally and providing access to resources to further your development • Apogee offers regular all team, in-person meetings to build relationships and problem solve