Regulatory Writing Manager — Lead Submissions & Strategy

Precigen, Inc; Germantown (MD); On-site; USD 100,000 - 120,000; Full time

Job summary

Precigen, Inc. in Germantown, MD, is seeking a Manager of Regulatory Writing to oversee regulatory writing for assigned programs and contribute to messaging strategy. The role reports to the SVP, Regulatory Affairs and collaborates across functions to ensure timely, compliant submissions.

The candidate will manage external writers, oversee submission documents for eCTD, and ensure quality and consistency across project plans in a fast-paced biotech environment.

Qualifications

• Bachelor’s degree in life sciences or relevant field.
• 4+ years of experience in regulatory affairs writing in Biotech/Pharmaceutical industry.
• Strong understanding of global regulatory requirements.

Responsibilities

• Independently manage regulatory writing activities across assigned programs.
• Author or oversee authoring of regulatory submission documents (IND/CTA, CTD/BLA/MAA) for eCTD submissions.
• Quality control review of documents for clarity, grammar, formatting and flow.

Skills

Regulatory writing

Cross-functional collaboration

Attention to detail

Time management

Verbal & written communication

Education

Bachelor’s degree in life sciences

Job description

Precigen, Inc. in Germantown, MD, is seeking a Manager of Regulatory Writing to oversee regulatory writing for assigned programs and contribute to messaging strategy. The role reports to the SVP, Regulatory Affairs and collaborates across functions to ensure timely, compliant submissions.

The candidate will manage external writers, oversee submission documents for eCTD, and ensure quality and consistency across project plans in a fast-paced biotech environment.