ResumeProof

Role vocabulary

ATS resume keywords for Pharma Regulatory Affairs

These are the 25 terms our scorer checks a Pharma Regulatory Affairs resume against. It is the same list the free check uses, published in full.

Check my resume against these Build a Pharma Regulatory Affairs resume

The vocabulary

Coverage is 25 of the 100 points. Sixty percent of this list is full marks, so you do not need all of it, and stuffing every term in is penalised separately.

  • pharmaceutical
  • regulatory affairs
  • dossier
  • ctd
  • ectd
  • anda
  • dmf
  • usfda
  • cdsco
  • ema
  • who gmp
  • gmp
  • glp
  • gcp
  • validation
  • qualification
  • change control
  • deviation
  • capa
  • batch record
  • stability study
  • audit
  • quality assurance
  • pharmacovigilance
  • sop

The eight questions for Pharma Regulatory Affairs

The guided builder asks these, in this order, and turns each answer into a line on the page. Nothing is written that you did not type.

  1. 1.How many dossiers or submissions have you prepared or filed?
  2. 2.Which markets and agencies have you filed into?
  3. 3.What is your approval rate or number of queries received per filing?
  4. 4.How many products or molecules are in your portfolio?
  5. 5.How many audits or inspections have you faced, and what was the outcome?
  6. 6.How many change controls or variations have you managed in a year?
  7. 7.What is the largest submission you have owned end to end?
  8. 8.How many people or cross functional teams do you coordinate for a filing?
Answer them and see your score before paying

Words are the easy half

A resume can carry every term above and still be rejected, because coverage says what you know and nothing about what you delivered. The heaviest category on the rubric is evidence: how many of your bullets carry an actual figure.

Seven in ten is full marks. Most resumes we see manage two.

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