Global Regulatory Science Lead — Onsite, Equity

Scientific Search; Chatham (NJ); On-site; USD 185,000 - 200,000; Full time

Job summary

Scientific Search seeks an Associate Director of Regulatory Science to advance global clinical regulatory compliance for investigational and marketed products. You will manage submission packages, health authority responses, and cross-functional collaboration across INDs, CTAs, BLAs, and MAAs.

The role reports to the regulatory affairs leadership, requires strong writing and leadership, and offers onsite work in Chatham, NJ with competitive compensation and equity options.

Qualifications

• Bachelor's/Master/Doctorate in life sciences or related field with progressive regulatory or clinical development experience.
• 10+ years regulatory experience or 8+ with advanced degree.
• Experience managing staff and preparing regulatory submission modules.

Responsibilities

• Lead Health Authorities direct reports by delegating projects, timelines, and quality output.
• Manage day-to-day staff activities, including hiring, training, and coaching.
• Review clinical data and summaries for regulatory compliance and quality standards.
• Prepare regulatory submission sections and written summaries for INDs, CTAs, NDAs, BLAs, MAAs.
• Coordinate with CROs and external consultants during submissions.
• Maintain regulatory documentation governance and cross-functional collaboration.

Skills

Leadership

Regulatory strategy

Cross-functional collaboration

Regulatory submissions

Project management

Written and oral communication

Education

Bachelor's degree in life sciences or technical discipline

Master's degree in life sciences or technical discipline

Doctorate in life sciences or technical discipline

Tools

eCTD preparation and filing

Job description

Scientific Search seeks an Associate Director of Regulatory Science to advance global clinical regulatory compliance for investigational and marketed products. You will manage submission packages, health authority responses, and cross-functional collaboration across INDs, CTAs, BLAs, and MAAs.

The role reports to the regulatory affairs leadership, requires strong writing and leadership, and offers onsite work in Chatham, NJ with competitive compensation and equity options.