SPE-Reg Affairs-Med Writing

About the role

This hybrid role of Senior Professional Regulatory Affairs and Medical Writing focuses on preparing high quality regulatory documents and product submissions that comply with global life sciences standards and internal policies while supporting research and development teams.

What you'll do

• Collaborate with regulatory affairs and research and development teams to prepare comprehensive regulatory reports that clearly communicate product safety efficacy and…
• Develop structured regulatory documentation by transforming complex scientific findings and business requirements into accurate concise and compliant narratives that…
• Coordinate regulatory product specialist activities by aligning documentation content with evolving product strategies indications and risk profiles to ensure consistent…
• Conduct detailed regulatory domain analysis to interpret guidelines policies and standards and translate them into practical documentation plans and templates that…
• Perform regulatory business analysis by mapping business processes timelines and data dependencies to create clear documentation workflows that reduce rework and support…

What you need

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