(Sr.) Manager, Regulatory Affairs Strategy

4 weeks ago


Trenton, United States Atlas Search Full time

We are currently partnered with a growing biopharmaceutical company in need of a Manager/Sr. Manager of Regulatory Affairs Strategy to join their team. This company currently has an FDA approved product on the market with a robust pipeline in Rare Disease, Hematology and Neuroscience. This role is responsible for developing, implementing, and leading short/long term global regulatory strategies that support the success of their pharmaceutical products. Duties & Responsibilities: Serves as a liaison to FDA and provides strategic input with the regional regulatory leads responsible for ex-US regulatory activities. May provides 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 Assess and communicate 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 support in generation and submission of briefing books, meeting preparations. 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. Requirements: Advanced degree (Masters, PharmD, PhD, MD) preferred Experience in Oncology/Rare Disease is preferred 3+ years of regulatory experience within industry The annual base salary range is $160,000 to $175,000. Actual compensation offered to the successful candidate may vary from posted hiring range based upon geographic location, work experience, education, and/or skill level, among other things. Details about eligibility for bonus compensation (if applicable) will be finalized at the time of offer.

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