Teams at Secura Bio

The Director/Senior Director of Regulatory Affairs leads regulatory strategy, ensures compliance, manages submissions, collaborates across teams, and oversees product approvals.

Manage document control and training within the Quality Management System (QMS) to ensure GxP compliance. Oversee ACE eDMS administration, document change control, record archival, training curricula, SOPs, metrics, inspection readiness, and cross-functional coordination to maintain regulatory and quality standards.

Drive KOL insight gathering and trend analysis to inform Copiktra brand strategy. Coordinate with KAM, MAR, MSL, Legal/Compliance and Marketing to support speaker programs and advisory boards, identify regional marketing opportunities, raise awareness with key customers, and prepare for future launches and indications.