Associate Director/Director, Clinical Regulatory Writing
Core
Lead communications strategy and delivery for Cardiovascular, Renal and Metabolism (CVRM) clinical programs, shaping submission strategies from development through approval and lifecycle management.
Role type
Senior IC clinical regulatory writing director
Builds
Clinical regulatory submissions (e.g., NDA/MAA) and responses for complex drug development programs
Domain
Pharmaceutical/Biotech, Cardiovascular/Renal/Metabolism
Required skills
Medical/regulatory writing, complex communication program leadership, drug development lifecycle knowledge, regulatory requirements expertise, cross-functional team management, document quality standards enforcement, stakeholder influence, best practice innovation, team mentorship
Preferred skills
PhD in Life Sciences, recognized industry expert reputation
Technologies
None stated
Responsibilities
Lead large cross-functional teams to deliver business-critical submission content; Define and own clinical Submission Communication Strategy (cSCS) for major submissions; Ensure consistency and compliance across clinical-regulatory documents; Steer authoring teams through regulatory response periods; Represent Clinical Regulatory Writing on governance teams; Mentor and develop Clinical Regulatory Writing leaders
Seniority
Director, strategic leadership and team management
