Regulatory Affairs Consultant – Clinical Regulatory Affairs

🕒 il y a 27 jours

🇺🇸 États-Unis – Télétravail

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

🚔 Conformité

🦅 Parrain de Visa H1B

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Parexel

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1983

⚕️ Assurance santé

🧬 Biotechnologie

💊 Pharmaceutique

💰 Venture Round en 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

Parexel est l'une des plus grandes organisations de recherche clinique (CRO) au monde, fournissant des services complets pour le processus de développement clinique de la Phase I à IV. L'entreprise se spécialise dans la gestion de portefeuille, la gestion des essais cliniques, la stratégie réglementaire, l'accès au marché et la gestion du cycle de vie des produits biopharmaceutiques. Parexel vise à accélérer la mise sur le marché de médicaments qui changent la vie en tirant parti de son expertise clinique, réglementaire et thérapeutique. Avec une équipe mondiale de plus de 21 000 professionnels, Parexel s'efforce d'intégrer les perspectives des patients et des conceptions d'essais innovantes pour développer des traitements dans des domaines thérapeutiques tels que l'oncologie, les neurosciences, les maladies rares et plus encore. Elle se concentre sur la fourniture d'essais cliniques centrés sur le patient et efficaces.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

• 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