SME-Reg Affairs-Med Writing

About the role

Serve as a subject matter expert in regulatory affairs and medical writing for life sciences projects applying deep regulatory domain knowledge to develop compliant documentation and optimize regulatory business processes. Collaborate in a hybrid work model with global stakeholders to support research and development activities ensuring precise communication and alignment with regulatory and standards requirements.

What you'll do

• Collaborate with cross functional regulatory and research teams to design and refine documentation strategies that align with global regulatory and standards compliance…
• Develop comprehensive regulatory submissions using regulatory Veeva and other approved platforms to ensure accurate tracking documentation integrity and alignment with…
• Prepare medically accurate and evidence based documents including clinical overviews summaries and technical narratives that clearly support research and development…
• Analyze regulatory domain knowledge and regulatory affairs guidelines to interpret evolving regulations and transform them into practical documentation practices and…
• Coordinate regulatory business analyst activities by translating clinical and research insights into structured regulatory product specialist documentation that supports…

What you need

• 3–6 yrs of experience
• Writing
• Regulatory affairs
• Communication
• Any graduate