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Senior Regulatory Affairs Leader - Submissions & Strategy

Job in Germantown, Montgomery County, Maryland, 20875, USA
Listing for: Precigen, Inc
Full Time position
Listed on 2026-10-11
Job specializations:
  • Management
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 110000 - 130000 USD Yearly USD 110000.00 130000.00 YEAR
Job Description & How to Apply Below

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.

This is an excellent position to take on the Senior Regulatory Affairs Leader
- Submissions & Strategy role at Precigen, Inc.

We are currently recruiting a Senior Regulatory Affairs Leader
- Submissions & Strategy for our team in Germantown, MD, United States.

This is a great opportunity to take on the Senior Regulatory Affairs Leader
- Submissions & Strategy role at Precigen, Inc.

As a Senior Regulatory Affairs Leader
- Submissions & Strategy, you will play an important part at Precigen, Inc in Germantown, MD, United States.

Position Requirements
10+ Years work experience
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