SME-Reg Affairs-Med Writing

About the Role

Serve as a subject matter expert in regulatory affairs and medical writing for life sciences projects. Apply 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.

Key Responsibilities

• Collaborate with cross-functional regulatory and research teams to design and refine documentation strategies aligning with global regulatory and standards compliance requirements, supporting timely product approvals and updates.
• Develop comprehensive regulatory submissions using Veeva and other approved platforms, ensuring 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, clearly supporting 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.
• 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.
• Provide expert guidance on regulatory and standards compliance for life sciences regulatory projects, ensuring 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 for 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 craft documentation supporting safe and effective use.
• Monitor regulatory affairs and research and development timelines to prioritize medical writing tasks and ensure high-quality deliverables are submitted within agreed regulatory milestones.
• Evaluate existing regulatory business processes and recommend practical enhancements to improve data consistency, document version management, and audit readiness.
• Coordinate with regulatory domain knowledge experts to validate scientific content and ensure complex technical concepts are presented clearly and concisely for regulatory agencies.
• Document hybrid day shift working practices and collaboration expectations to support stable operations and knowledge transfer.

Requirements & Tech Stack

• Regulatory Veeva
• English (written communication)

Qualifications

• Strong regulatory domain knowledge and hands-on experience in life sciences regulatory documentation, including work on regulatory affairs and research and development submissions.
• Veeva expertise to manage document workflows, metadata, and version control.
• Experience as a regulatory product specialist to create structured product documentation describing indications, benefits, risks, and compliance status.
• Regulatory business analyst capabilities to interpret business requirements and transform them into detailed regulatory documents and process descriptions.
• Deep understanding of regulatory and standards compliance and life sciences regulatory expectations.
• Practical involvement in regulatory business process services and regulatory affairs to identify process optimization opportunities.

Certifications

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