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TAPPS · Lansing, Michigan
TAPPS is posting this position on behalf of our client, Quantum Regulatory Solutions, LLC.
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.
Agency Interaction & Risk Management
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.
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.
Details
| Company | TAPPS |
| Location | Lansing, Michigan |
| Type | FULL TIME |
| Niche | Management and organisation analysts |