Sr. Manager / AD of Regulatory Affairs Strategy

About the OpportunityOur client is a growing biopharmaceutical company in need of a Sr. Manager/Associate Director of Regulatory Affairs Strategy to join their team. This role is responsible for developing, implementing, and leading short/long term global regulatory strategies that support the success of their pharmaceutical products.The annual base salary range is $140,000 to $170,000. 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.Job ResponsibilitiesServe as a liaison to FDA and provide strategic input with the regional regulatory leads responsible for ex-US regulatory activities. May provide oversight to regulatory consultants and vendors where applicableProvide regulatory strategic support and guidance across all functionsRoutinely perform regulatory precedence and competitive intelligence researchContribute to identification of potential issues/gaps and propose creative risk mitigation strategies to address gaps affecting optimal and timely submission and approvalAssess and communicate regulatory requirements to ensure development activities are in compliance with applicable regulations and guidelinesSupport and/or lead the planning and execution of global health authority interactions including support in generation and submission of briefing books, meeting preparationsAssist and/or lead 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 guidelinesInterpret and communicate health authority correspondence effectively and quickly to senior leadership and project teamsJob RequirementsAdvanced degree (Masters, PharmD, PhD, MD) preferredExperience in Oncology/Rare Disease is preferred3+ years of regulatory experience within industry