ICON Strategic Solutions · 1 day ago

Global Regulatory Lead - United States, Part Time

United States

Part-time

Remote

Director/Executive

10+ years exp

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Pharmaceuticals

Actively Hiring

Hiring Manager

Lauren Gaffney

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Responsibilities

Provide strategic, operational, and tactical regulatory insight on pre-approval and post-approval activities globally

Help guide the organization on the appropriate filing strategy, and coordinate across disciplines to ensure timely filings

Oversee regulatory affairs vendors involved in marketing authorization filings and help ensure high quality interactions with regulators

Working with the rest of the argenx regulatory team, provide hands-on contributions to regulatory filings including INDs, BLAs, and MAAs, and other areas as requested

Provide regulatory leadership with post-approval activities including application maintenance activities such as drug registration and listing, payment of program user fees

Monitor, interpret, and communicate changes to the global regulatory landscape as required

Serve as the regulatory affairs business partner to local commercialization teams

Partner with medical, legal, quality, PV, and distribution teams to ensure regulatory input is provided in a timely matter to support business decisions

Serve as the conduit between strategy within the assigned project team and the broader global regulatory and development teams

Qualification

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Regulatory AffairsGlobal LeadershipFDA RegulationsDrug Development ProcessOrphan Drugs ExpertiseRegulatory Documents DevelopmentInteracting with Regulatory AuthoritiesPharmDPharmaceutical ExperienceAffinity with Science

Required

Minimum 10 years of regulatory affairs experience within biopharmaceutical organizations, of which at least 5-7 years must have been in global leadership roles with a focus on major regulatory regions such as FDA, EMA, or PMDA

A thorough understanding of the drug development process with expertise in orphan drugs, along with knowledge of the developing landscape of regulations and guidelines, specifically in United States

Demonstrated ability to coordinate the development of critical regulatory documents involved in the approval of medicines with a focus on the FDA

Affinity with science and ability to interact with scientists and clinicians

Experience interacting with regulatory authorities, especially the FDA and EMA