Senior Manager, Regulatory Affairs Project Management

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Apogee Therapeutics

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51 - 200 Mitarbeiter

🧬 Biotechnologie

💊 Pharmazie

💰 €149.000.000 Series B im 2022-12

Biotechnology • Pharmaceuticals

Apogee Therapeutics ist ein biopharmazeutisches Unternehmen im klinischen Stadium, das sich auf die Entwicklung neuartiger Biologika zur Behandlung von Entzündungs- und Immunerkrankungen konzentriert. Das Unternehmen zielt auf bedeutende Märkte in den Bereichen entzündliche und immunologische Erkrankungen ab, wie z. B. atopische Dermatitis, Asthma, chronisch obstruktive Lungenerkrankung, eosinophile Ösophagitis und andere verwandte Zustände. Apogee Therapeutics strebt an, den aktuellen Behandlungsstandard zu verändern, indem es Antikörpertherapeutika vorantreibt, die auf etablierte biologische Mechanismen abzielen und das Potenzial haben, dermatologische, respiratorische und gastroenterologische Probleme zu adressieren. Das Unternehmen ist dazu verpflichtet, ein psychologisch sicheres Arbeitsumfeld zu schaffen, während es innovative Behandlungsoptionen für Menschen mit diesen Erkrankungen priorisiert.

Beschreibung

• 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

🎯 Anforderungen

• 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

🏖️ Vorteile

• 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