Regulatory Writing Consultant

We are looking for an experienced Regulatory/Medical Writer who is ready to step into a more consultative, client-facing role. While you’ll bring deep hands-on expertise in regulatory document authorship, this position is focused less on day-to-day writing and more on guiding clients, providing best-practice recommendations, and ensuring the strategic and compliant delivery of high-quality regulatory documents.

What you’ll do

• Act as a trusted advisor to clients on regulatory writing deliverables, offering guidance on structure, compliance, and best practices.
• Oversee and review a broad range of documents (e.g., CSRs, IBs, PLSs) to ensure alignment with ICH/GxP/GPP standards.
• Partner closely with client teams, offering scientific and regulatory insight that adds value beyond document production.
• Mentor and collaborate with writing teams, leveraging your background to ensure accuracy, clarity, and regulatory compliance.
• Represent the writing function confidently in meetings, workshops, and client interactions.

What we’re looking for

• Strong background as a medical/regulatory writer within pharmaceutical companies, CROs, or regulatory service providers.
• Proven familiarity with regulatory guidelines (ICH, GxP, GPP) and regulated deliverables (CSRs, IBs, PLSs).
• Excellent communication skills, with the ability to translate technical writing expertise into client-facing consulting.
• A detail-oriented, organized professional who can balance writing quality with broader consulting impact.
• Experience in scientific communications a plus, but regulatory writing expertise is essential.

Why join us?

This is a unique opportunity for a writer who wants to evolve into a strategic, consultative role. You’ll still leverage your writing background every day, but instead of focusing on drafting, you’ll guide clients, shape deliverables, and influence best practices in regulatory writing.