Regulatory Affairs Consultant – Clinical Regulatory Affairs

🕒 vor 12 Tagen

🇺🇸 Vereinigte Staaten – Remote

⏰ Vollzeit

🟡 Mittelstufe

🟠 Senior

🚔 Compliance

🦅 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

• Serve as Regulatory Affairs Lead for 5+ clinical studies within a dedicated client team • Provide strategic regulatory guidance to cross‑functional study teams navigating complex and evolving global requirements • Assess regulatory impact of protocol amendments, informed consent form (ICF) updates, and other study changes • Determine whether updates are substantial or non‑substantial in accordance with applicable regulations • Advise teams on regulatory pathways, processes, and solutions for emerging trial issues • Plan, coordinate, and author health authority meeting requests and scientific advice packages, as required • Lead preparation and coordination of responses to health authority questions and requests for information • Manage regulatory communication strategy for assigned studies • Ensure timely and compliant submission of annual reports and safety updates • Participate in regular study team meetings to track trial progress and proactively surface regulatory considerations • Provide clear and accurate updates to client management on regulatory status, risks, and upcoming milestones • Act as the primary regulatory point of contact for study teams and client stakeholders • Maintain accurate, current regulatory tracking systems in accordance with Parexel and client standards • Ensure all regulatory documentation meets quality expectations and agreed timelines • Support ad hoc study needs and contribute to continuous improvement and departmental initiatives

🎯 Anforderungen

• At least 5 years of regulatory affairs experience to include previous clinical regulatory affairs experience • A minimum of a bachelor’s degree in a scientific or technical discipline, advanced degree strongly preferred • Knowledge of FDA Regulations and previous experience with FDA meeting requests and other packages. Experience with other global Health Authorities and applicable regulations are strongly preferred • Project management / leadership experience • Excellent interpersonal and intercultural communication skills, both written and verbal • Client-focused approach to work (Quality) • Results orientation • Teamwork and collaboration skills • Consulting skills • Critical thinking and problem-solving skills • Proficiency in local language and extensive working knowledge of the English language

🏖️ Vorteile

• Work in a dedicated partnership model with strong client trust and visibility • Be part of a global organization known for regulatory leadership and scientific excellence • Collaborate with talented, purpose‑driven colleagues across functions and regions • Make a meaningful contribution to clinical programs that put patients first