Director of Regulatory Affairs

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

As head of the Regulatory Affairs function, you will provide full leadership over the planning and execution of the company's pharmaceutical regulatory strategy, overseeing drug registration and submission activities in China (NMPA), the United States (FDA), the European Union (EMA), and other regions. Your mission is to ensure that products obtain marketing authorization through the optimal, compliant regulatory pathway. You will own end-to-end lifecycle regulatory management spanning preclinical development through post-marketing, and partner with R&D, Manufacturing, Quality, and Clinical functions to drive project timelines, delivering core support for the commercialization of the company's product pipeline.

Key Responsibilities

1. Develop global regulatory strategies and timelines for the company's core products together with senior management, and ensure their execution; plan submission pathways such as Breakthrough Therapy designation, Priority Review, and Orphan Drug designation.

2. Monitor domestic and international regulatory developments, anticipate the impact of policy changes on the regulatory strategy, and adjust plans in a timely manner.

3. Lead the preparation, review, and submission of all regulatory dossiers, including IND, NDA/BLA, ANDA, and supplements, ensuring full compliance with regulatory requirements.

4. Interface with regulatory authorities (e.g., CDE, FDA), chair key meetings (e.g., pre-IND, End-of-Phase 2, pre-NDA), and follow through on review feedback.

5. Coordinate with R&D, Clinical, CMC, and Quality functions to ensure the scientific soundness, consistency, and completeness of regulatory submissions.

6. Provide a regulatory perspective and recommendations on clinical protocols, manufacturing processes, and quality specifications.

7. Manage post-marketing changes, re-registration, annual reports, and other lifecycle maintenance activities to ensure ongoing product compliance.

8. Build and lead a high-performing regulatory team; develop SOPs; optimize regulatory workflows and the document management system; cultivate the professional capabilities of team members and raise the department's overall efficiency and compliance standards.

9. Manage the department, including but not limited to departmental budgeting, performance management, and talent pipeline development.

10. Complete other tasks assigned by leadership.

Qualifications

• Bachelor's degree or above in Pharmaceutics, Chinese Materia Medica, Bioengineering, Biotechnology, or a related discipline.
• Ten (10) years or more of regulatory affairs experience in the biopharmaceutical or pharmaceutical industry, including at least three (3) years of regulatory team management experience.
• Familiarity with domestic and international registration and approval workflows; proven track record leading innovative drug submissions to approval with FDA, EMA, and other overseas regulators.
• In-depth knowledge of domestic and international drug registration laws, regulations, guidelines, and technical requirements, with the ability to accurately interpret and apply them in practice.
• Solid pharmaceutical science foundation; familiarity with the technical requirements across drug R&D, manufacturing, and quality control; ability to independently review and author high-quality regulatory submissions.
• Extensive experience interacting with regulatory authorities; capable of effectively handling regulatory inspections and information requests, and resolving technical and compliance issues throughout the registration process.
• Excellent team management, organizational coordination, and cross-functional communication skills; able to lead a team to deliver results efficiently.
• Strong sense of responsibility, professionalism, and resilience under pressure; able to thrive in a multi-project, parallel-work environment.
• Strong written communication, logical reasoning, and problem-solving skills.
• Proficiency in Microsoft Office and regulatory-related management systems.