Regulatory Affairs – CMC Consultant
Core
Regulatory CMC expert supporting pharmaceutical and self-care product development, lifecycle management, and global regulatory submissions.
Role type
Senior Regulatory Affairs CMC Consultant
Builds
CTD Module 2.3 and 3 documentation, regulatory submissions, and CMC strategies for new products and post-approval changes.
Domain
Pharmaceutical regulatory affairs and CMC
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CTD Module 2.3 and 3 expertise, global regulatory knowledge, cross-functional collaboration, project management, risk assessment, manufacturing/formulation/analytical/stability knowledge
Preferred skills
OTC/self-care product experience, multi-region regulatory knowledge, health authority interaction
Technologies
CTD documentation systems, regulatory submission platforms
Responsibilities
Lead or support CMC strategy for new product development and lifecycle management; Develop, review, and maintain CTD Module 2.3 and 3 documentation; Assess CMC changes for regulatory impact and compliance; Partner with R&D, Manufacturing, and Quality teams to resolve CMC issues; Support regulatory agency interactions and responses; Manage regulatory risks and mitigation strategies.
Seniority
Senior, hands-on IC