Sr Dir Regulatory Intelligence & FDA Engagement
Core
Establishing and leading a global regulatory intelligence capability to proactively identify, assess, and drive implementation of regulatory requirements and emerging trends for Medical Devices, Pharmaceuticals, Cosmetics, and Combination Products.
Role type
Senior Director, Regulatory Intelligence & FDA Engagement
Builds
Centralized regulatory intelligence function supporting all product categories and global markets
Domain
Healthcare / Life Sciences / Regulatory Affairs
Deliverable
dashboards & analysis
Required skills
Global regulatory intelligence strategy, enterprise-wide impact assessments, cross-functional action planning, regulatory risk forecasting, FDA enforcement response authoring, remediation plan development, regulatory negotiation
Preferred skills
Leading enterprise-level FDA remediation programs, establishing regulatory intelligence functions, operating across multiple major regulatory jurisdictions (FDA, EMA, Health Canada, PMDA, TGA, MFDS), supporting enterprise-wide quality transformation
Technologies
None stated
Responsibilities
Develop and execute global regulatory intelligence strategy; Direct enterprise-wide impact assessments for significant regulatory changes; Prepare dashboards summarizing regulatory changes, compliance risks, industry trends, and enforcement themes; Lead preparation of responses to FDA Form 483 observations, Warning Letters, and other regulatory actions; Guide cross-functional teams through regulatory negotiations and remediation activities
Seniority
Senior Director, enterprise leadership