Global Regulatory Strategy Lead (NDAs/BLAs/MAAs)

TAPPS; Boston (MA); Remote; USD 250,000 - 350,000; Full time

Job summary

Quantum Regulatory Solutions, LLC is seeking a Principal Regulatory Strategist to lead global regulatory strategies and major submissions. This remote role reports to the Head of Regulatory Affairs and requires up to 20% travel.

You will mentor a team of regulatory professionals, manage high-stakes regulatory dossiers (NDAs, BLAs, MAAs), and collaborate with clients to align development plans with regulatory requirements across US and international health authorities.

Qualifications

• Bachelor’s degree in life sciences, toxicology, pharmacology, engineering, or related field.
• Minimum 20 years of life sciences industry experience.
• 15+ years focused on strategic regulatory direction and global submissions.
• Experience authoring and leading NDAs, BLAs, and MAAs.
• Proven ability to build and leverage relationships with FDA, EMA, and other health authorities.

Responsibilities

• Provide high-level regulatory oversight to client project teams.
• Lead development, review, and lifecycle management of regulatory dossiers (INDs, CTAs, BLAs, DMFs, NDAs, MAAs).
• Develop expedited pathways strategies (Fast Track, Breakthrough Therapy, Orphan Drug, 505(b)(2)).
• Mentor internal regulatory specialists and publishers.
• Represent regulatory agencies in meetings and negotiations with US FDA and Health Authorities.

Skills

Regulatory strategy

Submission leadership

FDA/EMA liaison

Team mentorship

Business development

Education

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

Advanced degree (Ph.D., Pharm.D., or Master’s)

Tools

Microsoft Word

Excel

Cloud-based regulatory tools

Job description

Quantum Regulatory Solutions, LLC is seeking a Principal Regulatory Strategist to lead global regulatory strategies and major submissions. This remote role reports to the Head of Regulatory Affairs and requires up to 20% travel.

You will mentor a team of regulatory professionals, manage high-stakes regulatory dossiers (NDAs, BLAs, MAAs), and collaborate with clients to align development plans with regulatory requirements across US and international health authorities.