Senior Consultant (CMC) Australia
Core
Senior Consultant providing strategic, technical, and regulatory advice for Chemistry, Manufacturing, and Controls (CMC) development of human medicinal products.
Role type
Senior IC regulatory consultant (CMC)
Builds
Regulatory strategies, development plans, and authorship of regulatory documents (INDs, MAA/BLA, DMFs) for clients.
Domain
Life sciences / Regulatory affairs / CMC
Required skills
CMC regulatory strategy, drug development planning, regulatory document authorship, multi-jurisdiction program leadership, agency interaction, team leadership, recombinant proteins/peptides/vaccines/biosimilars/ATMPs/RNA-DNA products knowledge
Preferred skills
MAA/BLA experience, early-stage to marketing authorization planning, scientific conference presentation
Technologies
MS Office
Responsibilities
Provide strategic CMC advice, lead multi-jurisdiction programs, represent clients in agency interactions, author regulatory documents, line manage and mentor staff, support business development.
Seniority
Senior, hands-on IC with mentorship