Jobs at Secura Bio

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.

Lead KOL insight gathering to inform brand strategy for Copiktra, support speaker programs and advisory boards, collaborate with KAM, MAR, and MSL teams, identify regional marketing opportunities, and prepare for future product launches and indications.

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