Principal Regulatory Strategist

TAPPS; Colorado; Remote; USD 180,000 - 280,000; Full time

Benefits offered by this job

Flexible schedule

Job summary

Quantum Regulatory Solutions, LLC seeks a Principal Regulatory Strategist to lead global regulatory strategies, oversee major submissions, and advise clients on complex NDA, BLA, and MAA programs. You will mentor a team of specialists and act as the primary interface with health authorities, including FDA.

This remote role reports to the Head of Regulatory Affairs, requires travel up to 20%, and demands a proven track record of leading filings through approval with deep knowledge of US FDA

Qualifications

• Bachelor’s degree in life sciences or related field required.
• Advanced scientific degree preferred with applied training in regulatory drug development.

Responsibilities

• Provide independent, high-level regulatory oversight to client project teams to support overarching drug development plans.
• Direct the development, review, and lifecycle management of key regulatory dossiers (INDs, CTAs, BLAs, DMFs, NDAs, MAAs).
• Author and evaluate strategic pathways for expedited programs (Fast Track, Breakthrough, Orphan Drug, 505(b)(2)).
• Lead regulatory reviews of documents (IBs, CSRs, clinical protocols).
• Represent the US Agent/regulatory liaison with FDA and Health Authorities.
• Lead meeting preparation and execution strategies for high-stakes client meetings.
• Identify regulatory risks and develop mitigation plans for executive teams.
• Mentor internal teams of specialists, strategists, and publishers.
• Partner with growth teams for business development and credibility in pitches.

Skills

Regulatory strategy

Global submissions

FDA interactions

Leadership

Mentorship

Technical writing

Project management

Education

Bachelor’s degree in life sciences, toxicology, pharmacology, engineering, or related field

Ph.D., Pharm.D., or Master’s degree in relevant field

Tools

Microsoft Word

Excel

Regulatory software

Job description

TAPPS is posting this position on behalf of our client, Quantum Regulatory Solutions, LLC.

About Us

Quantum Regulatory Solutions, LLC provides comprehensive services targeted to the needs of companies at all stages of development. Our goal is to work collaboratively with pharmaceutical and biotechnology companies to develop innovative, customized, strategic programs that help our clients obtain and maintain the regulatory applications necessary to study investigational drugs and biologics, in pursuit of market approval. Founded by industry veterans, with more than 75 years of combined regulatory affairs experience, Quantum brings strategic insight and hands‑on expertise across small molecules, biologics, cell and gene therapies, and medical devices.

Our team provides tailored support across regulatory strategy, health authority interactions, regulatory submissions, CMC, project management, labeling, and medical writing. We work collaboratively with clients to navigate complex regulatory requirements and achieve critical development and commercialization milestones. Grounded in excellence, integrity, accountability, and respect, Quantum combines deep scientific knowledge with a practical, client‑focused approach to helping bring innovative therapies to market.

Position Overview

Quantum is seeking a Principal Regulatory Strategist to serve as an elite regulatory advisor, blending advanced technical mastery with decisive tactical execution. In this role, you will lead the formulation of complex global regulatory strategies, oversee major regulatory submissions, and provide high‑value consultation directly to Quantum’s clients. This position requires a definitive, firsthand track record of leading successful marketing applications through approval, with specific expertise in NDAs, BLAs and MAAs. Acting as a critical point of escalation for high‑stakes regulatory hurdles, you will also serve as a foundational mentor to our internal team of specialists, strategists, and publishers. This remote position will report to Head of Regulatory Affairs and it will require travel up to 20%.

Key Responsibilities:

Strategic Consulting & Submissions

• Operational Guidance: Provide independent, high-level regulatory oversight to client project teams to support overarching drug development plans.
• Submission Leadership: Direct the comprehensive development, review, and lifecycle management of critical dossiers including INDs, CTAs, BLAs, DMFs, NDAs, and MAAs.
• Pathways Innovation: Author and evaluate strategic positioning for expedited pathways, including Fast Track, Breakthrough Therapy, Orphan Drug, and 505(b)(2) applications.
• Quality Assurance: Execute rigorous strategic reviews of high‑stakes documents, including Investigator Brochures (IBs), Clinical Study Reports (CSRs), and clinical protocols.
• Health Authority Representation: Act as the designated US Agent or official regulatory representative in direct negotiations with the FDA and global Health Authorities.
• Meeting Preparation: Lead the preparation, coaching, and execution strategies for high‑stakes client meetings with regulatory agencies.
• Risk Mitigation: Proactively identify potential client regulatory risks, delivering structured risk evaluations and mitigation frameworks to executive management.

Leadership & Growth

• Team Mentorship: Elevate internal team capabilities by mentoring and training regulatory specialists, strategists, and digital publishers.
• Business Development: Partner with growth teams to provide technical regulatory credibility during client pitches, capability presentations, and proposal stages.

Experience & Qualifications:

Education

• Required: Bachelor’s degree in life sciences, toxicology, pharmacology, engineering, or a related field.
• Preferred: Advanced scientific degree (Ph.D., Pharm.D., or Master’s degree) with applied training explicitly relevant to strategic regulatory drug development.

Work Experience & Technical Skills

• Industry Tenure: Minimum of 20 years of relevant life sciences industry experience.
• Domain Focus: At least 15 years strictly focused on strategic regulatory direction and global submissions.
• Filing Track Record: Firsthand experience successfully authoring, managing, and leading major filings (NDAs, BLAs, and MAAs) through health authority approval.
• Agency Relationships: Proven capability to build, manage, and leverage collaborative relationships with the FDA, EMA, and other major Health Authorities.
• Regulatory Compliance: Deep-rooted knowledge of US FDA regulations required; broad knowledge of global regulatory requirements (EMA, Health Canada) is highly preferred.
• Leadership & Communication: Exceptional written and verbal communication skills with a proven ability to provide technical direction to cross‑functional teams.
• Software Proficiency: Fluent in core productivity tools (Microsoft Word, Excel) and highly adaptable to modern cloud‑based regulatory applications.