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    Head of Regulatory Affairs Oncology - Rockville, MD, United States - Scientific Search

    Scientific Search
    Scientific Search Rockville, MD, United States

    4 weeks ago

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    Description

    Head of Regulatory Affairs – Oncology

    Location: NJ. Role can be remote on the East Coast with travel into NJ 1-3x per month. Scientific Search has partnered with a growing midsized publicly traded Oncology company in NJ that has tasked us in finding them a Head of Regulatory Affairs. This position will provide regulatory expertise and leadership to ensure that the company meets its objectives. The candidate will be responsible for working with global health authorities to appropriately position innovative products while also ensuring efficient and compliant internal regulatory operations. Responsibilities
    • Leads global strategic and operational planning, management, support and execution of regulatory activities.
    • Builds and manages strong relationships with cross-functional internal colleagues, as well as between the regulatory team and regulatory agencies, external CROs, regulatory consulting groups, and other third parties.
    • Defines strategies and coordinates the execution of regulatory submissions including, but not limited to: Investigational New Drug applications, New Drug Applications and equivalent international filings.
    • Serves as a primary liaison to US FDA, EMA, and other key market Health Authorities, driving interactions and overseeing Health Authority meeting preparation throughout the organization.
    • Manages, coaches, and mentors direct reports.
    Requirements
    • Bachelor's degree in a scientific discipline is required, advanced degree is a plus with a minimum of 10 years of progressively increasing experience in a pharmaceutical or biotechnology organization including significant experience in a Regulatory Affairs leadership role.
    • Oncology experience required.
    • Regulatory CMC and CDx experience are preferred
    • In-depth knowledge of relevant regulatory guidelines and requirements, with a focus on the US and EU
    • Proven record of success in gaining regulatory approval through relationship building with global health authorities; experience with INDs, NDAs, CTAs, and post-marketing/life cycle management (e.g. variations, renewals, labeling)
    How To Apply We'd love to see your resume, but we don't need it to have a conversation. Send us an email to #J-18808-Ljbffr
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