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Director of Regulatory Affairs

Company: CELLO HEALTH LIMITED
Location: Morristown
Posted on: November 19, 2021

Job Description:

Innovative Science Solutions (ISS) is a leading scientific consulting firm serving the worldwide pharmaceutical, biotechnology, and medical device industries. We are a team of skilled scientific and regulatory consultants that deliver distinctive approaches to fulfill the complex business needs of industry and counsel. Blending scientific expertise and business acumen, ISS integrates strategy, support, and analysis for regulated products to provide results-driven solutions with superior outcomes.As the Director of Regulatory Affairs, you will play an important role in the management of clients, billable projects, and junior staff. You will be responsible for ensuring that all scientific content is accurate and well organized as well as evaluating and analyzing scientific information to support the underlying integrity of the projects. We will expect you to be an expert at understanding the processes adhered to by pharmaceutical and medical device firms as well as working with scientific data and nomenclature. You must be highly skilled at effectively communicating complex scientific principles to non-scientists, scientists, and physicians.Responsibilities:* Manage FDA Advisory Committee Programs: Play a senior management role in projects involving FDA Advisory Committee management, including, leading team meetings, managing project timelines, developing slide decks, and drafting briefing books.* Manage Regulatory Project: Play a senior role in provide guidance to clients relating to drug and medical device safety and efficacy evaluations and activities related to FDA product approvals.* Scientific Summary and Analysis: Review scientific studies and data relevant to a particular scientific issue and provide meaningful written and/or oral critical analysis and integration as to how it affects the client objectives.* Client Interaction: Provide oral and written communication with clients to convey project status, interim reports, and final project deliverables.* Program Management: Supervise client projects and ensure that they are completed with high degree of accuracy and quality and that they are within budget and on time.* Budget Preparation and Oversight: Provide budget estimates for project proposals and ensure that projects stay within budget parameters.* Management and Oversight: Oversees junior staff on client-related projects and administrative responsibilities.* Marketing Initiatives: Conceive, formulate, and implement effective marketing initiatives designed to identify leads and expand project work.* Review and Revise Work Product: Review written work product for clarity and style and revise as necessary.* Expand Projects: Possess ability to identify opportunities to expand existing client projects into larger and more profitable jobs.

Keywords: CELLO HEALTH LIMITED, Knoxville , Director of Regulatory Affairs, Executive , Morristown, Tennessee

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