Assoc Director, Regulatory Affairs CMC
Core
Define and advance global CMC regulatory strategy for combination products and devices, ensuring regulatory integration into development and lifecycle planning.
Role type
Senior IC regulatory affairs lead (combination products/devices)
Builds
Global regulatory submissions (IND/CTA, NDA/BLA/MAA) and lifecycle management for combination products and devices
Domain
Biopharmaceuticals / Medical Devices
Required skills
Global CMC regulatory strategy, device and combination product development, regulatory filing management, cross-functional stakeholder influence, risk-based regulatory planning, health authority interaction preparation
Preferred skills
Knowledge of global regulatory landscapes for devices, ability to translate technical CMC data into regulatory strategy, leading through ambiguity
Technologies
Regulatory submission platforms, knowledge management tools
Responsibilities
Define global CMC regulatory strategy for device and combination product programs; Lead global regulatory planning for complex submissions (IND/CTA, NDA/BLA/MAA); Provide strategic advice on development pathways and design controls; Interpret global regulations to shape regulatory strategies; Lead cross-functional evaluation of regulatory risks; Partner with global/regional colleagues for coordinated strategy; Prepare for health authority interactions; Influence stakeholders to incorporate regulatory implications early; Lead initiatives to improve regulatory processes and knowledge management.
Seniority
Senior, strategic partner & team lead