Principal Consultant (Director), Regulatory Strategy

Overview/About Lumanity

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: Strategy & Insights, Value, Access & Outcomes, and Medical Strategy & Communications.

Responsibilities / Position overview

We are seeking a highly skilled biotech and pharmaceutical life sciences professional with deep global regulatory expertise to join our Clinical and Regulatory team as a Principal Consultant (Director), Regulatory Strategy. This role, part of our broader Global Strategy and Insights Consulting Team, is critical in guiding clients through all stages of product development and commercialization and leading regulatory strategies and submissions.

The Principal Consultant, Regulatory Strategy will play a key role in driving the growth and delivery of our Regulatory Strategy, Advising, and Implementation business. In this role, you will partner with client companies to develop and implement regulatory strategies and submissions from pre-IND through commercialization. The Principal Consultant will also play a key role in business development and sales, thought leadership and brand representation, and team oversight to ensure the delivery of exceptional work.

Key responsibilities include:

• Strategic Technical Leadership; provide regulatory guidance to and lead the regulatory activities on behalf of clients, and oversee FDA Advisory Comittee programs
• Client & Project Management; lead and oversee client projects and maintain strong client relationships
• Quality Assurance; review and ensure accuracy of scientific studies and data, providing analysis and integration to support client objectives
• Business Development; actively seek new business opportunities and identify new clients, contributing to and participating in pitch planning and delivery, proposal review and account planning.
• Team Leadership & Development; hire, develop, lead, and retain top talent that delivers high-quality work, foster a collaborative and high-performing work environment
• Scientific & Regulatory Expertise; evaluate and analyze scientific information and communicate scientific and regulatory principles to scientific and non-scientific audiences

Qualifications

• Advanced degree in a life sciences field (e.g., PhD, MPH, MBA) or regulatory affairs/science is preferred
• Extensive experience in regulatory affairs within the pharmaceutical and biotechnology industry, across different types of products (i.e. biologics, drugs, cell/gene therapies), and therapeutic areas (i.e. CNS, oncology, immunology)
• Proven track record in project management and regulatory submissions, including experience with regulatory body meetings (e.g., PIND, EOP2, FDA Advisory Committees).
• Proficient in scientific/medical data and nomenclature, able to effectively interpret and communicate complex scientific principles.
• Strong proficiency with Microsoft Word, Outlook, Excel, and PowerPoint.
• Ability to work independently and collaboratively in a fast-paced environment.
• Excellent oral and written communication skills, with a passion for presenting scientific data.

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
• Flexible paid time off program 10 paid holidays
• Flexible spending accounts for health and dependent care
• Health savings account option with employer contribution
• Employee Assistance Program
• Paid short-term and long-term disability coverage
• Company-paid life insurance coverage at 1.5x annual salary
• Paid parental leave and more

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