Associate Director, Regulatory Affairs Strategy (...

Our client is currently seeking an Associate Director, Regulatory Affairs Strategy.Essential Duties and Responsibilities:Serves as a regulatory lead to FDA and provides strategic input with the regional regulatory leads responsible for ex-US regulatory activities. Provides oversight of regulatory consultants and vendors where applicable.Provides regulatory strategic support and guidance to project teams.Mentors and manages direct reports.Performs research on regulatory precedence and competitive intelligence as needed.Contributes to identification of potential issues/gaps and proposes creative risk mitigation strategies to address gaps affecting optimal and timely submissions and approvals.Assesses and communicates regulatory requirements to ensure development activities are in compliance with applicable regulations and guidelines.Supports and manages regulatory CROs in the planning and execution of US and ex-US global health authority interactions including support of preparation and submission of meeting requests, briefing books, meeting preparations, Pediatric Investigational Plans (PIPs), Orphan Drug Designation applications, Fast Track and Breakthrough Designation requests, Rare Pediatric Disease Designations, etc., as applicable.Assists and/or leads in 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.Participates in project team meetings and provides updates on regulatory activities.Qualifications & Requirements:BS/BA in Life Sciences in a relevant field required; advanced degree strongly preferred (PharmD, MD, PhD) with 7-10 years of regulatory experience in the branded biotech/pharma industry supporting regulatory strategy, submissions, drug promotion/advertising and US labeling.Working knowledge of prescription drug laws, ICH and FDA guidelines, FDA regulations and other health authority guidelines.Experience in rare disease/accelerated approvals preferred.Regulatory Affairs Certified is a plus.#J-18808-Ljbffr

Created: 2025-03-04