Regulatory affairs (RA) in pharma is a critical function that ensures pharmaceutical products meet legal and safety standards before they reach the market. It involves compliance with national and international regulations governing drug development, approval, manufacturing, marketing, and post-market surveillance.
- SOP for Test and Examination Licence for New Drug Product from State Drug Control Authority
- SOP for Test Report of New Drug Substance from Central Drugs Laboratory (CDL)
- SOP for Preparation of Dossier
- SOP for Preparation of PSUR
Regulatory Affairs (RA) in pharma is the function responsible for ensuring that a medicinal product is developed, manufactured, tested, documented, and marketed in compliance with the applicable laws and health authority requirements. RA acts as the bridge between a pharmaceutical company and regulators, translating scientific and quality data into approvable dossiers and maintaining product compliance throughout its lifecycle.
Key roles of Regulatory Affairs
1) Product registration and approvals
RA prepares and submits applications for product approval, such as CTD/eCTD dossiers, including:
- Quality (CMC): formulation, manufacturing process, controls, stability
- Nonclinical and clinical summaries (as required)
- Labeling, package insert, artwork, and patient information
2) Regulatory strategy
RA defines the best pathway for approval based on:
- Product type (generic, new drug, biologic, vaccine)
- Market requirements (India, US, EU, etc.)
- Data expectations, timelines, and risk management
This includes decisions on reference products, bioequivalence approach, and bridging requirements.
3) Compliance and lifecycle management
After approval, RA ensures the product stays compliant by managing:
- Variations/changes (site, equipment, process, specifications, suppliers)
- Renewals, market authorizations, and periodic updates
- Safety reporting coordination (with Pharmacovigilance)
- Post-approval commitments and responses to authority queries
4) Coordination with internal teams
RA works closely with:
- QA/QC for GMP compliance and investigations
- R&D for development reports and comparability
- Manufacturing/Engineering for tech transfer and change control
- Clinical/Medical for study documents and labeling claims
5) Regulatory intelligence
RA monitors new guidelines, pharmacopeial updates, and changing expectations (e.g., data integrity, nitrosamines, Annex 1 updates) and converts them into internal action plans.
Why RA is critical
A strong RA team reduces approval delays, prevents costly compliance gaps, supports smooth inspections, and protects patients by ensuring products meet quality, safety, and efficacy requirements at every stage.