Ariv Academy logo Ariv AcademyEmpowering Minds, Enriching Futures
← All careers with PCM or PCB
PCM or PCB streamEntrance: TN paramedical counsellingPharmacy & healthcare industry

Regulatory Affairs Specialist

Regulatory affairs specialists get medicines, vaccines and medical devices approved by regulators, and keep them compliant after launch.

Class 11–12 subjectsPCM or PCB
Entrance / admissionTN paramedical counselling / CUET UG
DegreeB.Pharm / B.Sc + M.Pharm or PG in Regulatory Affairs
Duration5–6 years

Your route, step by step

  1. 1Class 11–12: PCB or PCMChemistry is important.
  2. 2B.Pharm or B.Sc life scienceB.Pharm through Tamil Nadu counselling; B.Sc on Class 12 marks or CUET UG.
  3. 3M.Pharm (Regulatory Affairs) or a PG diplomaSpecialised regulatory training helps.
  4. 4Join industryRegulatory associate, then manager.

What a regulatory affairs specialist does

  • Prepare approval dossiers for regulators
  • Track rules in India and export markets
  • Review labels, safety data and quality documents
  • Answer regulator questions and audits

Entrance exams & admission

Where you may work

Pharmaceutical, biotech, vaccine and medical-device companies, and contract research organisations.

Well-known colleges in and near Tamil Nadu

  • JSS College of Pharmacy, Ooty
  • College of Pharmacy, Madras Medical College

Official links

Links checked: Oct 2026. Always confirm dates and rules on the official site.

Outlook

India exports medicines worldwide, and every product needs regulatory approval, so this role is in steady demand.

Specialise later

  • Drug regulatory affairs
  • Medical devices
  • Biologics & vaccines
  • Export markets
  • Pharmacovigilance