Regulatory Strategy Director

🕒 il y a 27 jours

🏄 California, Massachusetts – Distant

🏄 California – Remote 🍂 Massachusetts – Remote

💵 $150 000 / an

⏰ Temps Plein

🔴 Expert

🚔 Conformité

🦅 Parrain de Visa H1B

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Premier Research

Site WebLinkedInTous les Emplois

1001 - 5000 employés

🧬 Biotechnologie

⚕️ Assurance santé

💊 Pharmaceutique

💰 Venture Round en 2016-10

Biotechnology • Healthcare Insurance • Pharmaceuticals

Premier Research est une organisation de recherche clinique de premier plan, dédiée à soutenir les entreprises biotechnologiques innovantes dans la transformation d'idées révolutionnaires et de sciences de pointe en nouveaux traitements médicaux. Avec des capacités étendues en recherche clinique et développement de produits, Premier Research propose une gamme complète de services, incluant la consultation réglementaire, des études en situation réelle et de phase tardive, ainsi qu'une expertise dans divers domaines thérapeutiques tels que les maladies rares, la thérapie cellulaire et génique, l'oncologie, la dermatologie et la pédiatrie.

Description

• Develop and execute regulatory program strategies and contingencies for assigned projects • Lead both US and ex-US regulatory teams on assigned projects • Develop and implement creative approaches to ensure regulatory success • Provide efficient and effective regulatory representation with clients as well as across the organization and act as a key player in interactions with the Food and Drug Administration (FDA) and other regulatory agencies • Serve as the primary point of contact and interface for FDA/EMA/national agencies on assigned projects • Lead the preparation of submissions, which may include INDs, briefing documents, orphan drug applications, breakthrough designations, and NDAs/BLAs/MAAs and others

🎯 Exigences

• Bachelor’s degree, or international equivalent from an accredited institution, in science or health related field; Master’s Degree or PhD preferred • 12+ years of experience in the CRO, pharmaceutical, biotechnology or device/diagnostics industry; an advanced degree will be considered in lieu of a portion of industry experience • 8-9 years progressive regulatory affairs experience (US and/or ex-US) for a CRO/biotech/pharma of which 4+ years has been as a consultant • Demonstrated experience interacting with the Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulatory agencies • Demonstrated leadership experience in the opening of INDs and submission and approvals of NDAs/ BLAs/MAAs • Expert in the drug development process with experience in multiple phases (early and late stage, post-approval) in various therapeutic areas and product types (drugs, biologics, drug-drug combinations, drug-device combination products)

🏖️ Avantages

• health insurance • retirement plans • paid time off