StaffGlobalRegulatoryGPO

## Accountabilities Develop, implement, and execute global regulatory strategies ensuring compliance across product registration, lifecycle management, labeling, and promotional material governance. Oversee regulatory workflows and tools used to manage global product lifecycle activities, ensuring efficiency, consistency, and compliance. Define and maintain global labeling requirements and regulatory procedures, ensuring alignment with international regulations and internal standards. Review and govern marketing, advertising, promotional, and training materials (MAPSS) to ensure compliance with applicable regulatory requirements. Partner closely with Business Unit and Commercial Regulatory Affairs teams to align global strategies, share best practices, and drive cross-functional initiatives. Support regulatory readiness for internal and external audits, inspections, and global compliance assessments. Evaluate evolving global regulatory requirements and translate them into actionable guidance for stakeholders across the organization. Requirements Bachelor’s degree in biological sciences, biomedical engineering, chemistry, or related field with 9+ years of relevant experience; or Master’s degree with 7+ years; or PhD with 4+ years. Strong understanding of global regulatory frameworks, with the ability to critically assess applicability and impact on products and processes. Experience in regulatory affairs, ideally within in-vitro diagnostics or other highly regulated life sciences industries. Ability to develop clear, structured regulatory documentation, assessments, and stakeholder-ready presentations. Strong cross-functional collaboration skills, with experience working in matrixed and global environments. Excellent written and verbal communication skills, with the ability to translate complex regulatory topics into actionable business guidance. Proficiency in Microsoft Office tools and regulatory documentation systems. Strong leadership, influence, and decision-mak