Regulatory Affairs_2620463579.jpg

Writing for Compliance: Regulatory & GxP Writing for Life Sciences

Develop industry-relevant regulatory writing skills through a flexible online course designed to fit your schedule.

Request More Information

Learn Writing Skills for Real-World Compliance

Whether you're new to regulatory writing or looking to strengthen your expertise, you'll gain practical skills you can apply immediately to improve documentation quality and help reduce compliance risk. This online short course equips you with the skills to create clear, concise, and compliant documentation in regulated environments.  

  • Complete 5 modules across 4 weeks of flexible online learning 
  • Learn core GxP documentation principles for real-world writing scenarios 
  • Produce audit-ready documentation for SOPs, deviations, CAPAs, and regulatory content 
  • Learn to use AI and writing tools responsibly while maintaining data integrity, accountability, and compliance standards 

Why MCPHS? 

With over 200 years of experience, Massachusetts College of Pharmacy and Health Sciences delivers career-focused education aligned with the needs of both individuals and organizations, informed by strong connections to Boston’s biotech and pharmaceutical community. 

#1

ISSUE FOR FDA

The #1 drug inspection issue cited by the FDA over the past 10 years: procedures not in writing or not fully followed.

$71,700

Average salary

Quality Assurance Specialist
(Payscale, 2026)

2X+

drug quality assurance inspections

FDA drug quality assurance inspections have more than doubled between 2022 and 2025.

Other Professional Learning Opportunities

Understanding Regulatory Affairs: Strategic Insight for Life Sciences Teams

Gain a clear understanding of how regulatory requirements influence the product lifecycle and how regulatory strategy impacts key business decisions.

Understanding Drug Safety: Foundations of Pharmacovigilance

Understand the critical role of pharmacovigilance in informing risk-benefit decisions in modern healthcare.

Students walking down the street in front of the MCPHS Griffin building.

Ready to take the next step?

Register for a course or email us to explore your options.