Vice President, Nonclinical Emerging Therapies

TL;DR

Vice President, Nonclinical Emerging Therapies (Regulatory Sciences): Conduct regulatory activities for nonclinical development of drugs, biologics, and device products with an accent on emerging therapeutic modalities from discovery through approval. Focus on interfacing with clients and FDA, preparing scientifically valid submissions, leading agency interactions, and developing cost-effective approval strategies.

Location: United States, supports remote working; hybrid encouraged if within short commute of an office.

Company

Consulting firm providing end-to-end customizable solutions across product lifecycle for biotech, pharmaceutical, and med device organizations, with expertise in regulatory sciences, clinical research, quality, pharmacovigilance, and R&D technology.

What you will do

• Coordinate and balance priorities of corporate, scientific, and clinical stakeholders within product development teams.
• Review documentation supporting regulatory applications.
• Prepare timely, organized, and scientifically valid submissions to FDA.
• Participate in and lead meetings/teleconferences with regulatory agencies, focusing on nonclinical discussions.
• Develop and implement strategies for regulatory approval with optimal cost-effectiveness and compliance.
• Support new product development and business development efforts.

Requirements

• 10+ years in leadership positions in Regulatory Sciences within consulting or regulated drug/biologic development organizations.
• Experience leading teams of technical professionals.
• Master’s degree in Life Sciences (PhD preferred).
• Deep knowledge of regulatory pathways for drugs, biologics, and medical device combination products.
• Strong skills in engaging regulatory agencies, preparing briefing packages, and investigational/marketing applications.
• Excellent communication, analytical, and cross-functional collaboration abilities; ability to manage multiple projects.

Nice to have

• PhD in Life Sciences.

Culture & Benefits

• Commitment to diversity, equity, inclusion, and creating an authentic workplace.
• Support for remote working with hybrid options encouraged near offices.
• Encouragement of innovative, collaborative, and entrepreneurial spirits.
• Personal review of all applications by recruitment team, no AI screening; always receive application outcome.