Regulatory Writing Manager: Submissions & Strategy Lead

Precigen; Germantown (MD); Hybrid; USD 100,000 - 120,000; Full time

Job summary

Precigen in Germantown, MD seeks a Manager, Regulatory Writing to lead regulatory writing across programs and ensure timely, compliant submissions. The role reports to the SVP, Regulatory Affairs and involves cross-functional collaboration to align messaging with regulatory requirements.

Responsibilities include coordinating external writers, managing submission documents (IND/CTA, CTD/BLA/MAA), and performing QC to ensure quality and consistency in eCTD submissions.

Qualifications

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

Responsibilities

• Independently manage regulatory writing activities across assigned programs.
• Author or oversee authoring of regulatory submission documents for eCTD submissions.
• Ensure compliance with processes while managing writing review and quality.
• Lead regulatory writing activities for complex product submissions.
• Coordinate external writers to ensure messaging consistency and on-time delivery.
• Perform QC reviews of submission documents for clarity and accuracy.
• Other duties as assigned.

Skills

Verbal communication

Written communication

Cross-functional collaboration

Time management

Organizational skills

Attention to detail

Education

Bachelor’s degree in life sciences or relevant field

Job description

Precigen in Germantown, MD seeks a Manager, Regulatory Writing to lead regulatory writing across programs and ensure timely, compliant submissions. The role reports to the SVP, Regulatory Affairs and involves cross-functional collaboration to align messaging with regulatory requirements.

Responsibilities include coordinating external writers, managing submission documents (IND/CTA, CTD/BLA/MAA), and performing QC to ensure quality and consistency in eCTD submissions.