Remote 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

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