Global Regulatory Strategy Director – Pharma

CARsgen Therapeutics; Houston (TX); On-site; USD 180,000 - 260,000; Full time

Job summary

CARsgen Therapeutics in Houston, TX, seeks a senior Regulatory Affairs leader to drive global regulatory strategy across CDE, FDA, EMA, and other regions. You will own end-to-end lifecycle management from preclinical to post-marketing and partner with R&D, Manufacturing, Quality, and Clinical to accelerate product registrations.

This role requires a minimum of ten years in regulatory affairs, including at least three years in team management, and a proven track record with FDA/EMA filings.

Qualifications

• 10+ years of regulatory affairs experience in biopharmaceutical/pharma industry.
• Experience leading regulatory teams for multi-regional submissions.

Responsibilities

• Develop global regulatory strategies and timelines for core products; plan submission pathways.
• Monitor regulatory developments and adjust plans accordingly.
• Lead preparation, review, and submission of regulatory dossiers (IND, NDA/BLA, ANDA) and supplements.
• Interface with regulatory authorities (e.g., FDA, EMA, CDE); chair key meetings.
• Coordinate with R&D, Clinical, CMC, and Quality to ensure submission integrity.
• Provide regulatory perspectives on clinical protocols, manufacturing, and quality specs.
• Manage post-marketing changes, re-registration, annual reports, and lifecycle maintenance.
• Build and lead a high-performing regulatory team; develop SOPs and workflows.
• Manage department budgeting, performance management, and talent development.
• Complete other tasks assigned by leadership.

Skills

Regulatory strategy

Team leadership

FDA/EMA regulatory

Dossier submission

Cross-functional collaboration

Lifecycle regulation

Education

Bachelor's degree in Pharmaceutics/Biotech

Tools

Regulatory management systems

Job description

CARsgen Therapeutics in Houston, TX, seeks a senior Regulatory Affairs leader to drive global regulatory strategy across CDE, FDA, EMA, and other regions. You will own end-to-end lifecycle management from preclinical to post-marketing and partner with R&D, Manufacturing, Quality, and Clinical to accelerate product registrations.

This role requires a minimum of ten years in regulatory affairs, including at least three years in team management, and a proven track record with FDA/EMA filings.