Gestionnaire principal(e), Affaires réglementaires CMC
Core
Lead global CMC regulatory affairs for innovative biological products from preclinical to commercialization, ensuring timely submission of high-quality regulatory dossiers to health authorities worldwide.
Role type
Senior Regulatory Affairs Manager (CMC)
Builds
Regulatory submissions (IND/IMPD, BLA/NDA, QOS, CTA) and Module 3 content for biological products and combination products.
Domain
Biotechnology / Oncology / Immunology / Endocrinology
Required skills
CMC regulatory requirements, eCTD structure, Module 3 preparation (IND/IMPD, BLA/NDA/NDS), combination product documentation, Health Canada/FDA/EMA regulations, strategic regulatory planning, risk assessment, change control evaluation
Preferred skills
Experience with pre-filled syringes and auto-injectors, device-drug combination systems, scientific writing, oral communication, detail-oriented organization
Technologies
eCTD, QOS, CTA, IMPD
Responsibilities
Lead planning, drafting, review, and execution of global CMC regulatory submissions; Prepare responses to health authority questions; Provide strategic CMC regulatory advice and critically review technical documentation; Manage critical CMC regulatory timelines with Manufacturing, Quality, and Analytical Development teams; Maintain global regulatory knowledge and monitor changes; Identify CMC regulatory risks and mitigation strategies; Evaluate regulatory impact of CMC changes.
Seniority
Senior, hands-on IC