Spécialiste de la conformité réglementaire
Core
Support regulatory submissions, post-approval change controls, and manufacturing transfer dossiers for a liquid/solid/semi-solid pharmaceutical manufacturing site.
Role type
Regulatory Compliance Specialist (Quality Assurance)
Builds
Regulatory submissions (CTD), technical transfer dossiers, and manufacturing master files for global markets.
Domain
Pharmaceutical manufacturing / Regulatory Affairs
Required skills
GMP, regulatory submissions, change control, technical documentation, stability data, master file management, bilingual communication (French/English)
Preferred skills
CTD dossiers, post-approval changes, facility licenses, SAP, Veeva QualityDocs
Technologies
SAP, Veeva QualityDocs, Microsoft Office
Responsibilities
Prepare and review CTD sections for regulatory submissions; review technical transfer dossiers; maintain facility licenses and BPF renewals; respond to Health Canada and international authority requests; prepare specifications and stability data; act as expert in change control processes; review and approve manufacturing and packaging master files.
Seniority
Mid-level, hands-on IC
