Executive Director, Regulatory Affairs
Core
Leading global regulatory strategy and submission delivery for late-stage antibody-drug conjugate (ADC) biologics products.
Role type
Executive Director, Regulatory CMC (Biologics)
Builds
Global registration dossiers and post-approval strategies for new modality biologics
Domain
Biopharmaceuticals / Biologics / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Antibody Drug Conjugates (ADC), Biopharmaceuticals, Chemistry, Pharmaceutical Sciences, Regulatory CMC, Regulatory Submissions, Risk Analysis, Project Management, Executive Management, People Leadership
Preferred skills
None stated
Technologies
eCTD
Responsibilities
Lead the Regulatory CMC team for ADCs in late-stage development; Ensure successful development of global CMC regulatory strategy; Lead regulatory CMC deliverables from clinical studies to market applications; Communicate CMC regulatory strategy to executive management; Manage, coach, and develop CMC staff; Monitor changes in regulatory environment and perform risk assessments.
Seniority
Executive, Strategic Leadership
