Regulatory Affairs Director jobs in Newark, NJ

Overview / About us

Lumanity is dedicated to improving patient health by accelerating and optimizing access to medical advances.  We partner with life sciences companies around the world to generate evidence to demonstrate the value of their product, translate the science and data into compelling product narratives, and enable commercial decisions that position these products for success in the market. We do this through strategic and complimentary areas of focus: Asset Optimization and Commercialization, Value Access and Outcomes, Medical Strategy and Communications, and Real-World Evidence.

Responsibilities / Position overview

We are seeking a life-sciences professional with healthcare regulatory experience to serve as the Director of Regulatory Affairs within our Clinical and Regulatory team. This role sits within our wider Global Strategic Consulting Team, which serves our clients by mobilizing our scientific knowledge to interpret the data and create compelling narratives to guide their medical strategy and through regulatory challenges.

The Director of Regulatory Affairs plays a vital role in the management of clients, billable projects, and staff. This position is responsible for securing new business and expanding existing client projects as well as ensuring that scientific content is accurate and well organized and evaluating and analyzing scientific information to support the underlying integrity of the projects. This role requires an expert level understanding of processes adhered to by pharmaceutical and medical device firms, scientific data and nomenclature, as well as the ability to communicating complex scientific principles to non-scientists, scientists, and physicians.

In this Senior Management role, the Director of Regulatory Affairs will oversee and manage client projects and project budgets, ensuring high-quality and accuracy of all deliverables within the project timeline and in budget. This role also manages the FDA Advisory Committee programs and provides guidance to clients on drug and medical device safety and efficacy evaluations and activities related to FDA product approvals, and will review relevant scientific studies and data and provide analysis and integration on how client objectives are affected.

Qualifications

The ideal candidate will have an advanced degree in a life-sciences field, healthcare regulatory experience, and consulting experience in the pharmaceutical or medical device industry.

Additional Requirements and Qualifications

• 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 non‐scientists (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 fast‐paced 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 offer our employees a comprehensive benefits package that focuses on what matters to you – health and well-being, personal finances, professional development, and a healthy work/life balance:

• Competitive salary plus bonus scheme
• Medical, dental, and vision insurance options
• 401(k) plan with employer match
• Generous amount of paid time off annually 10 paid holidays
• Employee Assistance Program
• Company-paid short-term and long-term disability coverage
• Flexible spending accounts for health and dependent care
• Health Savings Account option with employer match and much more

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