Regulatory Writing Manager - Biotech Submissions Lead

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

Job summary

Precigen, Inc. in Germantown, MD, seeks a Manager of Regulatory Writing to lead regulatory messaging for assigned programs and ensure timely, compliant submission documents. Reports to SVP, Regulatory Affairs and collaborates cross-functionally across the organization.

The role requires a Bachelor’s in life sciences and 4+ years in biotech/pharma regulatory writing, with strong attention to detail, organizational and communication skills. On-site position.

Qualifications

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

Responsibilities

• Independently manage regulatory writing activities across assigned programs.
• Author or oversee submission documents for IND/CTA, CTD/BLA/MAA in eCTD format.
• Ensure timelines and quality by reviewing processes and resolving issues.
• Lead writing activities for complex drug submissions.
• Coordinate external writers to ensure consistent messaging.
• Perform QC reviews of submission documents.
• Other duties as assigned.

Skills

Regulatory writing

Cross-functional collaboration

Attention to detail

Project management

Education

Bachelor's degree in life sciences

Job description

Precigen, Inc. in Germantown, MD, seeks a Manager of Regulatory Writing to lead regulatory messaging for assigned programs and ensure timely, compliant submission documents. Reports to SVP, Regulatory Affairs and collaborates cross-functionally across the organization.

The role requires a Bachelor’s in life sciences and 4+ years in biotech/pharma regulatory writing, with strong attention to detail, organizational and communication skills. On-site position.