L. Laubscher (Williams)

• Regulatory Dossier Management: Prepared and managed regulatory dossiers, successfully converting four from VMRF to eCTD format to meet regulatory requirements.
• Cross-Functional Collaboration: Coordinated closely with internal teams, including R&D and Quality, to ensure alignment on regulatory requirements and address dossier deficiencies for audits, ensuring compliance and minimizing potential risks.
• Strategic Regulatory Planning: Developed and implemented strategies for regulatory approval and compliance in domestic and international markets, including:
  * Planning and executing submissions to SAHPRA for dossier variations
  * Managing international dossier submissions for registration
  * Successfully indexing a product with the FDA in the USA, with three additional products in progress

• Product Expertise and Training: Provided in-depth knowledge and training to internal teams, sales personnel, and clients on products, product features, and benefits. Conducted comprehensive onboarding sessions for new employees and delivered product-focused training to ensure seamless knowledge transfer.
• Product Marketing and Promotion: Developed and executed successful marketing strategies to enhance product visibility, driving business growth through social media content creation and management, event participation, and collaboration with marketing teams.
• Product Positioning and Analysis: Conducted market research and analyzed customer feedback to inform product optimization, positioning, and marketing efforts. Utilized insights to improve product offerings and enhance customer satisfaction.
• Scientific Research and Publication: Authored and published research findings in peer-reviewed journals and academic theses, contributing to the organization's scientific reputation and thought leadership. Collaborated with academic institutions and supervised student research projects to drive innovation and advance industry knowledge.
• Animal Ethics and Governance: Served as the Secretary of the in-house Animal Ethics Committee, overseeing proposal writing, student supervision, and record-keeping. Ensured adherence to regulatory requirements and industry best practices, promoting a culture of responsible animal research and welfare.

• Product Quality and Compliance Oversight: Spearheaded the evaluation and testing of products to ensure adherence to quality and compliance standards, guaranteeing the highest level of product integrity.
• Research Collaboration and Academic Supervision: Fostered partnerships with academic institutions on product-related research projects, supervising students and guiding their research endeavors. Notably, supervised four Master's students and one PhD student, which extended through to my role as Regulatory Affairs Manager.
• Animal Ethics Committee Establishment: Conceptualized and managed the development of an internal animal ethics committee from inception, establishing a framework for responsible and ethical research practices involving animals. This demonstrated leadership, initiative, and a commitment to upholding the highest ethical standards in research and product development.
• Product Performance Analysis and Insights: Conducted in-depth analysis of product performance data, providing actionable insights to inform business decisions. This involved:
  * Staying abreast of published research on company products to identify trends and areas for improvement
  * Investigating and addressing customer complaints to enhance customer satisfaction and product quality
  * Serving as the pharmacovigilance officer, ensuring the monitoring of product safety and efficacy
  

• Conducting independent research and published findings in academic journals. This included 6 peer-reviewed articles and supervision of two Masters students.
• Collaborated with academic and industry partners on research projects.
• Secured funding through grant applications and proposals.
• Supervised and mentored postgraduate students.
• Presented research findings at conferences and academic events.

Clinical Trial Operations Management: Oversaw the daily operations of clinical trials, guaranteeing strict adherence to protocols, and ensuring execution of trial logistics. Notably, played a pivotal role in conducting clinical trials for six new products, with four of them successfully registered with the South African Health Products Authority (SAHPRA) between 2021 and 2024.

• Clinical Research Collaboration and Academic Supervision: Cultivated partnerships with academic institutions on research projects, providing guidance and supervision to students, and contributing to the development of future industry professionals. This collaboration facilitated knowledge sharing, innovation, and growth within the organization and academia.
• Clinical Data Management and Reporting: Managed all report writing activities, specifically Module 5 of dossiers, ensuring high-quality documentation and compliance with regulatory requirements.
• Trial Documentation and Data Record-Keeping: Maintained accurate, up-to-date, and complete trial documentation and data records, including
• Animal Safety and Pharmacovigilance: Monitored animal safety throughout clinical trials, identifying and managing potential risks. Additionally, reported adverse events and ensured prompt, effective mitigation strategies were implemented to safeguard animal welfare and trial integrity.