Jeremy Kuyakana

Staff Regulatory Affairs Specialist @BD

Work with RA Manager and Platform Leaders to ensure timely execution of regulatory strategies with business objectives and customer results. • Assess regulatory pathways for new products, product modifications or product conversions; develops regulatory strategies and planning for submissions or support of customers’ regulatory submissions • Partner with and support Pharma customers in securing timely development, submissions, addressing health authority questions and regulatory drug-device combination products approvals. • Perform regulatory impact assessment of changes linked to the field of expertise and assigned platform. • Liaise with cross-functional and cross company teams to meet customer needs in driving new global markets. • Develop and maintains knowledge & awareness on assigned fields of expertise: identify applicable regulations and standards, perform regulatory intelligence/watch, educate appropriate contact partners. • Identify and communicate potential risks and mitigations to partners. • Support customers for regulatory advice and registration of their products and interact as needed with the U.S. regulatory agencies and EU Notified Bodies. • Review and/or approve product marketing claims and communication, Advertising/promotional materials, and labeling. • Conduct trainings on regulatory issues for staff and for business customers (e.g, Platform, R&D, Marketing and Pharma Partners) • Participate in internal/external trade, professional, and standards development organizations • Lead multiple projects with minimal direction.