Senior Manager, Regulatory Strategy

Emploi pas sur LinkedIn

🕒 il y a 2 mois

🇺🇸 États-Unis – Télétravail

💵 $160 000 - $180 000 / an

⏰ Temps Plein

🟠 Senior

🚔 Conformité

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Praxis

Site WebLinkedInTous les Emplois

11 - 50 employés

Fondée en 2002

🧬 Biotechnologie

⚕️ Assurance santé

🔬 Science

Biotechnology • Healthcare Insurance • Science

Praxis est une entreprise dédiée à la connexion des patients avec des opportunités significatives d'essais cliniques. En mettant l'accent sur la création de programmes de recrutement sur mesure, Praxis utilise une variété d'outils spécialisés et une vaste expérience dans divers domaines thérapeutiques pour s'assurer qu'ils atteignent les bons patients dans le monde entier. Fondée en 2002, l'entreprise souligne l'importance de l'engagement des patients et utilise des analyses de données sophistiquées pour améliorer le parcours des patients dans la recherche clinique.

Description

• Support the development and execution of global regulatory strategies for ongoing clinical-stage programs, with a strong focus on lifecycle management. • Lead regulatory activities for clinical development programs, including new IND submissions, protocol amendments, annual reports, safety updates, and global CTA maintenance. • Partner with Clinical Development, Nonclinical, CMC, and Translational teams to align regulatory strategy with evolving development objectives and timelines. • Prepare and manage regulatory submissions (e.g., IND amendments, new INDs, CTAs, briefing packages) in collaboration with internal stakeholders and external vendors. • Contribute to preparation for and participation in health authority interactions (e.g., FDA, EMA, MHRA), including meeting strategy, briefing document preparation, and response coordination. • Provide regulatory guidance to cross-functional teams on clinical trial design, patient selection, and regulatory requirements to support lifecycle activities. • Support planning for future marketing applications by ensuring development programs are conducted in alignment with global registration requirements. • Monitor and interpret evolving regulatory guidance and communicate potential impact on ongoing programs. • Contribute to regulatory intelligence efforts and continuous improvement of regulatory processes.

🎯 Exigences

• Advanced degree (PharmD, MS, or equivalent) in a life science or regulatory-related field preferred; six to ten years of experience in Regulatory Strategy within biotech/pharma. • Demonstrated experience managing IND lifecycle activities, including protocol amendments, new INDs, and global CTA maintenance. • Experience supporting health authority interactions and preparing regulatory briefing packages. • Experience in rare disease and/or neurological indications strongly preferred. • Understanding of accelerated regulatory pathways (e.g., orphan designation, breakthrough therapy) and their application to lifecycle strategy. • Strong project management skills and ability to manage multiple concurrent regulatory activities. • Excellent communication and collaboration skills.

🏖️ Avantages

• 99% of the premium paid for medical, dental and vision plans. • Company-paid life insurance, AD&D, disability benefits, and voluntary plans. • Dollar-for-dollar match up to 6% on eligible 401(k) contributions. • Long-term stock incentives and ESPP. • Discretionary quarterly bonus. • Extremely flexible wellness benefit. • Generous PTO, paid holidays, and company-wide shutdowns.