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VP, Regulatory Affairs

Company: Cello Health
Location: Morristown
Posted on: November 22, 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. The Vice President, Regulatory Affairs plays an important role in the management of clients, billable projects, and junior staff. This individual is responsible for developing and implementing the strategy for all ISS regulatory consulting projects as well as 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. The VP, Regulatory Affairs is expected to be an expert at understanding the processes adhered to by FDA-regulated industries, including pharmaceutical, medical device, and food as well as working with scientific data and nomenclature and to be highly skilled at effectively communicating complex scientific principles to non-scientists, scientists, and physicians. VP, Regulatory Affairs responsibilities include the following: * 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 Projects: 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. Requirements The VP, Regulatory Affairs should have the following skills and qualifications: * Advanced degree (preferred in a life science or related field) 15+ years experience * Relevant work experience; preferably in regulatory affairs and/or project management; previous experience with regulatory submissions, regulatory body meetings (e.g. FDA Advisory Committees) a plus * Proficient and comfortable with scientific/medical data and nomenclature * Ability to effectively communicate complex scientific and regulatory principles to nonscientists (as well as to scientists and healthcare professionals) * Proficient with Word, Outlook, Excel, and PowerPoint * Expert skills in internet searching and web browsing related to life sciences and regulatory affairs * Eagerness to work independently and in teams in a fastpaced environment * Excellent ability to interpret scientific charts, tables and figures and communicate summary of findings * Passion for producing and presenting scientific data in oral presentations or written reports Benefits We value our employees time and efforts. Our commitment to your success is enhanced by our competitive compensation and an extensive benefits package including paid time off, medical, dental and vision benefits and future growth opportunities within the company. Plus, we work to maintain the best possible environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning and culture.

Keywords: Cello Health, Newark , VP, Regulatory Affairs, Executive , Morristown, New Jersey

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