Home Regulatory Affairs Manager Resume template
Regulatory Affairs Manager resume template
A clean starting structure with example content grounded in what regulatory affairs managers actually do day to day, not generic filler. Download and replace the bracketed placeholders with your own details.
Which resume format should you use?
Reverse chronological
You have a steady work history. This is the format almost every recruiter and ATS expects by default.
Functional
You're changing fields or have gaps in your employment. Leads with skills rather than a job-by-job timeline.
Combination
You're early career or have worked consistently but for only a few employers. Blends a skills summary with a shorter chronological history.
This template uses the reverse chronological format: the one most regulatory affairs managers should default to, since most Australian recruiters and ATS software expect it.
Professional summary
Regulatory affairs manager with experience preparing and lodging dossiers for therapeutic goods and medical devices in Australia. Skilled at interpreting TGA and APVMA requirements, coordinating cross-functional responses and maintaining submission records in Veeva Vault. Known for turning complex regulatory detail into clear advice for product and research teams.
Key skills
- Regulatory compliance
- Regulatory and administrative law
- Risk and internal controls
- Project management
- Policy analysis and advice
- Veeva Vault
- MasterControl
- SAP
- Microsoft Excel
- TrackWise
- Stakeholder management
- Written communication
Experience: example bullet points
- Prepared and lodged registration dossiers with the TGA for a portfolio of prescription medicines, coordinating clinical, manufacturing and labelling data from three departments.
- Monitored changes to therapeutic goods, device and chemical regulations, turning updates into practical guidance for product and research teams and reducing last-minute submission rework.
- Coordinated responses to regulator questions and audit findings, tracking each action in Veeva Vault until it was closed and keeping the review on schedule.
- Maintained submission tracking systems and regulatory records, giving commercial teams a clear view of approval timelines across multiple markets.
- Advised product teams on labelling, advertising and post-market compliance requirements, helping them avoid delays at the review stage.
Education
Bachelor degree in science, pharmacy, law, engineering or a related field, often followed by postgraduate study in regulatory affairs; some managers enter with a diploma or advanced diploma and extensive industry experience.
Keywords an ATS is likely to scan for
Applicant tracking systems match your resume against terms in the job ad before a person ever sees it. Only include the ones that actually apply to your experience, but if a term below matches something you've done, use the same wording the job ad uses.
- TGA
- Therapeutic Goods Administration
- APVMA
- Australian Pesticides and Veterinary Medicines Authority
- Therapeutic Goods Act 1989
- ARTG
- eCTD
- CTN
- CTX
- ISO 13485
- GMP
- PIC/S
- Veeva Vault
- MasterControl
- TrackWise
- post-market surveillance
- regulatory affairs
- dossier preparation
- product registration
- medical devices
- pharmaceutical
Getting past ATS screening
- Match the specific skills, certifications and terms used in the job ad, not just your own wording for the same thing.
- Keep formatting simple: no tables, text boxes, columns, headers/footers or graphics. Parsers frequently drop content placed in these.
- Submit as .docx or PDF unless the job ad specifies otherwise.
- Use standard section headings (Experience, Education, Skills) rather than creative alternatives.
- List your core skills and technical competencies in their own section so a keyword scan can find them instantly.
This is a starting point, not a guarantee of interviews. Tailor every bullet point to your own real experience and the specific job ad.