The role involves preparing tactical, compilation, writing, and revision of international registration dossiers for local and international authorities with minimal supervision
Job Summary
The role involves preparing tactical, compilation, writing, and revision of international registration dossiers for local and international authorities with minimal supervision.
The company is a global leader in diagnostic imaging sciences dedicated to improving lives through precision prevention and advanced diagnostic solutions.
Candidates must ensure all submitted documentation complies with applicable regulations, SOPs, and international guidelines such as ICH, BPF/GMP, and BPC/GCP.
Matching Summary
The role involves preparing tactical, compilation, writing, and revision of international registration dossiers for local and international authorities with minimal supervision.
Skills & Requirements
Must-have
Prepare regulatory submissions for Health Canada
Manage clinical trial applications and SNDS
Ensure compliance with ICH and GMP guidelines
Handle product labeling and monograph revisions
Coordinate cross-functional data collection
Nice-to-have
Experience in regulatory publication and submissions
Strong analytical and problem-solving skills
Ability to work autonomously with minimal supervision
Excellent written and oral communication skills
Collaborative team player with client orientation
Key Requirements
Bachelor's degree in Sciences (Microbiology, Chemistry, Biochemistry)
Experience in regulatory submission preparation
Knowledge of Canadian and international pharmaceutical regulations