Senior Manager/Associate Director, Regulatory Affairs Strategy Senior Manager/Associate Director, Regulatory  …

Hamlyn Williams
in Jersey City, NJ, United States
Permanent, Full time
Be the first to apply
Competitive
Hamlyn Williams
in Jersey City, NJ, United States
Permanent, Full time
Be the first to apply
Competitive
Senior Manager/Associate Director, Regulatory Affairs Strategy
Responsibilities:
  • Serves as a liaison to the FDA and provides strategic input with the regional regulatory leads responsible for ex-US regulatory activities. May provide oversight to regulatory consultants and vendors where applicable
  • Provides regulatory strategic support and guidance across all functions
  • Routinely performs regulatory precedence and competitive intelligence research
  • Contributes to identification of potential issues/gaps and proposes creative risk-mitigation strategies to address gaps affecting optimal and timely submission and approval
  • Assesses and communicates regulatory requirements to ensure development activities are in compliance with applicable regulations and guidelines
  • Supports and/or leads the planning and execution of global health authority interactions, including the generation and submission of briefing books and meeting preparations
  • Assists with and/or leads the planning and execution of major and life-cycle management maintenance submissions and responses to regulatory authorities related to INDs, amendments, NDAs, and supplements within company timelines and in accordance with regulations and guidelines
  • Interprets and communicates health authority correspondence effectively and quickly to senior leadership and project teams
Experience:
  • BS/BA in a relevant field required; advanced degree preferred (PharmD, MD, PhD)
  • 5 or more years of broad regulatory development experience in biotech/pharma industry, including 3 or more years of new drug regulated product strategy/submissions
  • Working knowledge of prescription drug laws, ICH guidelines, regulations, and health authority guidances/guidelines
  • Experience in oncology/rare disease preferred
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