Associate Director / Director, Regulatory Affairs CMC
Core
Develop and execute global regulatory CMC strategies for clinical and commercial stages of oncology therapeutics, including antibody-drug conjugates.
Role type
Senior IC regulatory affairs director (CMC)
Builds
Regulatory submissions (IND, CTAs, IMPD, annual reports, marketing applications) for targeted cancer therapies
Domain
Biotechnology / Oncology / CMC
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC strategy development, regulatory submission preparation, health authority interaction, cross-functional team leadership, knowledge of ICH/FDA/EMA guidelines, submission management software proficiency
Preferred skills
Advanced degree in scientific discipline, experience with small molecules and biologics
Technologies
Veeva RIM
Responsibilities
Develop and execute global regulatory CMC strategies; Author, review and manage CMC sections for regulatory submissions; Lead interactions with global health authorities on CMC topics; Collaborate with internal and external stakeholders to ensure regulatory compliance; Maintain current knowledge of global regulations and guidelines; Support regulatory inspections
Seniority
Director, hands-on IC