SME-Reg Affairs-Med Writing

Job Summary

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 clear 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 maintaining clear written communication channels in English and organizing documentation workflows that enable efficient coordination across onsite and remote stakeholders.
• Utilize regulatory product specialist skills to map product features indications and risk profiles to relevant regulatory frameworks and to craft documentation that supports safe and effective use for patients and healthcare systems.
• Monitor regulatory affairs and research and development timelines to prioritize medical writing tasks and ensure that all deliverables are produced with high quality and submitted within agreed regulatory milestones.
• Evaluate existing regulatory business processes and recommend practical enhancements that improve data consistency document version management and audit readiness across life sciences regulatory operations.
• Coordinate with regulatory domain knowledge experts to validate scientific content and ensure that complex technical concepts are presented in clear concise and accessible language for regulatory agencies.
• Document hybrid day shift working practices and collaboration expectations to support stable operations and knowledge transfer while ensuring that no travel requirements impact project continuity.

Qualifications

• Demonstrate strong regulatory domain knowledge and hands on experience in life sciences regulatory documentation including work on regulatory affairs and research and development submissions.
• Apply regulatory Veeva expertise to manage document workflows metadata and version control ensuring that all regulatory and medical writing outputs remain accurate and inspection ready.
• Use experience as a regulatory product specialist to create structured product documentation that clearly describes indications benefits risks and compliance status for diverse health markets.
• Draw on regulatory business analyst capabilities to interpret business requirements and transform them into detailed regulatory documents and process descriptions that support organizational decision making.
• Exhibit deep understanding of regulatory and standards compliance and life sciences regulatory expectations to ensure that medical writing outputs consistently support safe and ethical product use.
• Leverage practical involvement in regulatory business process services and regulatory affairs to identify opportunities for process optimization and to support efficient management of submission portfolios.

Certifications Required

Preferred certification in Regulatory Affairs such as RAC or equivalent life sciences regulatory credential.