Senior Regulatory Consultant – Regulatory Project/Program Manager

🕒 vor 1 Monat

🇺🇸 Vereinigte Staaten – Remote

⏰ Vollzeit

🟠 Senior

📋 Programmmanager

🦅 H1B-Visum-Sponsor

Dieses Unternehmen hat in der Vergangenheit H1B-Visa gesponsert.

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Parexel

WebsiteLinkedInAlle Stellen

10.000+ Mitarbeiter

Gegründet 1983

⚕️ Krankenversicherung

🧬 Biotechnologie

💊 Pharmazie

💰 Venture Round im 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

Parexel gehört zu den weltweit größten Auftragsforschungsinstituten (CROs) und bietet umfassende Services für den gesamten klinischen Entwicklungsprozess von Phase I bis IV. Das Unternehmen ist spezialisiert auf Portfolio-Management, Studienmanagement, Regulatory-Strategie, Market Access und Lifecycle-Management für Biopharmazeutika. Ziel von Parexel ist es, lebensverändernde Arzneimittel mithilfe seiner klinischen, regulatorischen und therapeutischen Expertise schneller auf den Markt zu bringen. Mit einem globalen Team von über 21. 000 Fachkräften integriert Parexel Patientenperspektiven und innovative Studiendesigns, um Therapien in Indikationsgebieten wie Onkologie, Neurowissenschaften, seltene Erkrankungen und mehr zu entwickeln. Im Fokus stehen patientenzentrierte und effiziente klinische Studien.

Beschreibung

• Partner strategically with Global Regulatory Leads to shape and execute forward-looking, globally aligned regulatory plans across all stages of development and post-marketing. • Translate regulatory strategy into integrated, actionable plans with clear milestones, critical paths, risks, and opportunities to support effective planning and decision-making. • Lead the execution of regulatory plans, ensuring alignment between day-to-day operations and broader strategic objectives across global programs. • Identify and propose innovative regulatory pathways and planning scenarios that align with global regulatory expectations and business objectives. • Collaborate closely with cross-functional teams and senior leadership to drive clarity, alignment, and accountability for regulatory deliverables, timelines, and interdependencies. • Facilitate Global Regulatory Subteam (GRST) meetings and other routine and ad hoc project review forums, ensuring meetings are purpose-driven, well-structured, and focused on decision-making, risk mitigation, and regulatory execution. • Apply project management best practices for meeting management and hygiene, including developing and distributing agendas in advance, defining objectives and discussion topics, maintaining action logs, documenting key decisions and next steps, tracking follow-up items to closure, and ensuring materials are stored and communicated appropriately. • Partner with Global Regulatory Leads and cross-functional stakeholders to maintain effective GRST governance, meeting cadence, stakeholder alignment, and communication flow across global and regional teams. • Anticipate and troubleshoot complex regulatory project and operational challenges, implementing scalable solutions that strengthen team effectiveness, process efficiency, and submission readiness. • Prepare and deliver strategic dashboards, reports, and scenario plans to senior stakeholders, translating regulatory progress and risks into actionable business insights.

🎯 Anforderungen

• BA/BS degree in a scientific, engineering, or healthcare discipline required; advanced degree (MS, PharmD, PhD) and/or PMP certification strongly preferred. • Minimum of 7 years of progressive experience in the pharmaceutical, biotechnology, or related life sciences industry, with at least 5 years in regulatory or regulatory program management. • Proven ability to partner on regulatory strategy and lead execution across all stages of product development, including IND/BLA/MAA submissions, global registration, and post-marketing activities. • Deep understanding of U.S. regulatory requirements with working knowledge of international (ex-U.S.) regulations and agency expectations. • Demonstrated success managing complex regulatory deliverables across cross-functional teams within a matrixed organization, while maintaining alignment to strategic priorities. • Hands-on experience with eCTD and a strong command of regulatory documentation, formatting, and submission strategy. • Experience supporting global development programs across multiple modalities or therapeutic areas is highly desirable. • Exceptional communication and influencing skills, with the ability to synthesize complex regulatory information and translate it into clear recommendations for senior leadership and global stakeholders.

🏖️ Vorteile

• Remote work opportunity • Professional development opportunities • Collaborative team environment • Innovation-driven culture