This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Principal Regulatory Medical Writer based in India.
This role offers the opportunity to lead the creation of high-quality regulatory and clinical documentation that supports the development and approval of innovative healthcare products.
The position requires advanced scientific writing expertise, strong knowledge of regulatory standards, and the ability to manage complex deliverables across multiple therapeutic areas.
You will collaborate with cross-functional teams including clinical operations, regulatory affairs, data management, and subject matter experts.
The role combines independent ownership, strategic client partnership, and technical leadership within a global healthcare environment.
You will contribute to improving patient outcomes by ensuring accurate, compliant, and impactful communication of scientific and clinical data.
This opportunity is ideal for experienced medical writers who enjoy mentoring others, solving complex challenges,



and driving excellence in regulatory submissions.
n

Accountabilities:
The Principal Regulatory Medical Writer will be responsible for independently developing and managing complex clinical and regulatory documents while ensuring quality, compliance, and timely delivery. The role requires solid collaboration with internal teams, clients, and scientific stakeholders to support successful clinical development programs.
Author, edit, and review high-quality clinical, safety, regulatory, device, diagnostics, and disclosure documents across different phases of research.
Develop complex regulatory deliverables, including protocols, clinical study reports, investigator brochures, informed consent forms, patient narratives, submission-level documents, and other regulatory materials.
Manage assigned medical writing projects, timelines, deliverables, and client expectations with minimal supervision.
Coo

📌 Principal Regulatory Medical Writer (India)
🏢 Jobgether
📍 India