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. The candidate will apply regulatory domain expertise to transform complex scientific and business information into transparent documentation that enables timely approvals supports patient safety and advances the company mission
Responsibilities
• Collaborate with regulatory affairs and research and development teams to prepare comprehensive regulatory reports that clearly communicate product safety efficacy and quality data for timely submission to global authorities.
• Develop structured regulatory documentation by transforming complex scientific findings and business requirements into accurate concise and compliant narratives that support product registrations and lifecycle management.
• Coordinate regulatory product specialist activities by aligning documentation content with evolving product strategies indications and risk profiles to ensure consistent messaging across all submissions.
• Conduct detailed regulatory domain analysis to interpret guidelines policies and standards and translate them into practical documentation plans and templates that streamline reporting activities.
• Perform regulatory business analysis by mapping business processes timelines and data dependencies to create clear documentation workflows that reduce rework and support audit readiness.
• Implement regulatory and standards compliance practices throughout medical writing tasks by applying relevant laws industry standards and internal procedures to minimize compliance risks.
• Engage with life sciences regulatory stakeholders to gather source information verify data integrity and resolve content gaps ensuring that all written deliverables reflect accurate and current scientific evidence.
• Prepare high q