Regulatory Strategy Director

🕒 May 29

🏄 California, Massachusetts – Remote

🏄 California – Remote 🍂 Massachusetts – Remote

💵 $150k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

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Premier Research

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 Venture Round on 2016-10

Biotechnology • Healthcare Insurance • Pharmaceuticals

Premier Research is a company dedicated to helping biotech companies transform groundbreaking scientific ideas into life-changing medical treatments. They specialize in clinical research and development, product development and regulatory consulting, and offer expertise in areas such as oncology, hematology, rare diseases, cell and gene therapy, and pediatrics, among others. Premier Research is committed to boosting clinical development strategies and guiding innovations from molecule to market. They provide a range of services that support biotech firms in navigating the complex path to medical approval, with a focus on rare diseases and innovative therapies.

📋 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

🎯 Requirements

• 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)

🏖️ Benefits

• health insurance • retirement plans • paid time off