Regulatory Affairs Specialist Sample CVs
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What makes a strong Regulatory Affairs Specialist CV
- Specify industry: pharmaceuticals, medical devices, food, cosmetics, chemicals, veterinary
- List regulatory agencies: TGA, FDA, EMA, Health Canada, PMDA, ANVISA
- Quantify submission outcomes: approvals obtained, timelines achieved, dossiers compiled
- Include CTD/eCTD preparation, variation management, and post-market surveillance experience
- Highlight labelling compliance, risk management files (ISO 14971), and UDI requirements
Key skills employers look for
Regulatory Submissions
CTD/eCTD, ARTG submissions, FDA 510(k)/PMA, EMA MAA, variation management
Agency Knowledge
TGA, FDA, EMA, PMDA, Health Canada — registration pathways, guidance interpretation
Post-Market
PMS, vigilance reporting, FSCA, CAPA management, labelling updates, renewals
Quality Systems
ISO 13485, 21 CFR Part 11, GMP/GCP, design dossiers, regulatory intelligence
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