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.
Responsibilities
• Collaborate with cross functional regulatory and research teams to design and refine documentation strategies that align with global regulatory and standards compliance requirements and support timely product approvals and updates.
• Develop comprehensive regulatory submissions using regulatory Veeva and other approved platforms to ensure accurate tracking documentation integrity and alignment with life sciences regulatory expectations.
• Prepare medically accurate and evidence based documents including clinical overviews summaries and technical narratives that clearly support research and development outcomes and regulatory decisions.
• Analyze regulatory domain knowledge and regulatory affairs guidelines to interpret evolving regulations and transform them into practical documentation practices and process improvements for the organization.
• Coordinate regulatory business analyst activities by translating clinical and research insights into structured regulatory product specialist documentation that supports transparent product positioning and risk communication.
• Review and refine regulatory business process services documentation to ensure consistency traceability and completeness across product lifecycles from early research stages through post approval commitments.
• Provide expert guidance on regulatory and standards compliance for life sciences regulatory projects ensuring that medical writing deliverables accurately reflect scientific data and regulatory expectations.
• Support hybrid work collaboration by maintainin