Senior Regulatory Affairs Leader - Submissions & Strategy

Precigen, Inc; Germantown (MD); On-site; USD 110,000 - 130,000; Full time

Job summary

Precigen, Inc in Germantown, MD is seeking a Senior Manager/Manager, Regulatory Affairs to lead global regulatory programs for pharmaceutical development, reporting to the VP Regulatory Affairs. The role focuses on IND/ BLA preparation and regulatory intelligence.

The position requires strong regulatory strategy, cross-functional leadership, and hands-on experience with FDA and international authorities, ensuring compliance across QA, CMC, preclinical and clinical teams.

Qualifications

• Five (5) years of direct regulatory affairs experience in biotech or pharmaceutical environment.
• Comprehensive knowledge of regional health authority regulations and global guidelines for pharmaceuticals, biologics and medical devices.
• Experience in compilation of Regulatory submissions using eCTD (electronic common technical document).

Responsibilities

• Support regulatory strategies for assigned programs to support development and marketing objectives.
• Participate in project team discussions on preclinical, clinical, and CMC aspects, providing regulatory guidance and timelines.
• Identify regulatory risks and develop mitigation strategies.
• Develop relationships with FDA and global regulatory authorities.
• Coordinate regulatory workflow and track timelines for areas of responsibility.
• Manage IND submission preparation and module 2 sections drafting/editing.
• Monitor FDA and global guidelines and train staff on applicable requirements.

Skills

Regulatory affairs

FDA communications

IND/DA submissions

Cross-functional leadership

Regulatory strategy

Biotech/pharma

eCTD experience

Education

Bachelor's degree in life science

Advanced degree preferred

Tools

eCTD submission software

Job description

Precigen, Inc in Germantown, MD is seeking a Senior Manager/Manager, Regulatory Affairs to lead global regulatory programs for pharmaceutical development, reporting to the VP Regulatory Affairs. The role focuses on IND/ BLA preparation and regulatory intelligence.

The position requires strong regulatory strategy, cross-functional leadership, and hands-on experience with FDA and international authorities, ensuring compliance across QA, CMC, preclinical and clinical teams.