The pharmaceutical and healthcare industry is highly regulated around the world. All this is possible due to regulatory guidelines followed globally, which help regulate the safe use of drugs and medical devices. In this highly regulated pharmaceutical and healthcare industry, two terms often used interchangeably, but with distinct meanings, are Regulatory Affairs (RA) and Regulatory Compliance (RC). Both functions make sure that the pharmaceutical products meet the government regulations and quality standards, but the focus, career paths and responsibilities differ significantly. In this blog, we will explore the difference between Regulatory Affairs and Regulatory Compliance, their roles in the pharmaceutical industry, and how you can build a successful career in each field.
What is Regulatory Affairs?
Regulatory Affairs primarily focuses on the entire process of obtaining and maintaining regulatory approvals for drugs, medical devices, or biologics, cosmetics, pharmaceuticals, food, or any other regulated product, which are approved and authorised for sale in their target markets. Regulatory Affairs teams act as the link between the company and various regulatory authorities, such as:
- CDSCO (Central Drugs Standard Control Organisation) India
- US FDA (Food and Drug Administration)
- FSSAI (Food Safety and Standards Authority of India)
- BIS (Bureau of Indian Standards)
- CPCB (Central Pollution Control Board)
- State-level FDA and Pollution Control Boards
- EMA ( European Medicines Agency)
- MHRA (UK) ( Medicines and Healthcare products Regulatory Agency)
Key Responsibilities Of Regulatory Affairs
- Preparing and submitting regulatory documents such as IND, NDA, ANDA, or DMF.
- Coordinating with various teams such as R&D, manufacturing, and quality teams to ensure regulatory readiness.
- Tracking and implementing regulatory changes or new guidelines issued by health authorities.
- Management of product registration, labelling, and post-approval variations.
- Oversee and ensure smooth market entry for pharmaceutical products.
Note: Regulatory Affairs ensures that products are developed, approved, and marketed in compliance with all applicable regulatory standards and timelines.
What is Regulatory Compliance?
Regulatory Compliance is an operational function that ensures the company’s day-to-day activities, such as regulatory operations, processes and systems, remain fully aligned with applicable laws, regulations and quality standards across all geographies, categories and functions. Once a product enters the market, the company’s responsibility doesn’t end. It intensifies.
Key Responsibilities in Regulatory Compliance
Regulatory compliance key responsibilities are more internally focused and broader in scope, spanning:
- Monitoring adherence to Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP).
- Monitoring ongoing compliance of products, labels, packaging, and marketing materials
- Managing audits and inspections by regulatory authorities and conducting internal audits
- Overseeing waste management obligations (such as EPR requirements under the Plastic Waste Management Rules)
- Managing corrective and preventive actions (CAPA).
- Tracking license renewals and certification timelines
- Ensuring supply chain partners meet regulatory expectations
- Managing incidents, recalls, and non-conformance corrective actions
Note: Regulatory Compliance ensures that every product and process within the organisation meets regulatory, ethical, and quality requirements at all times.
Key Difference Between Regulatory Affairs and Regulatory Compliance
| Aspects | Regulatory Affairs | Regulatory Compliance |
| Primary Focus | Product approval and lifecycle management | Ensuring continuous adherence to regulations and quality standards |
| Key Objective | Getting regulatory approval for new products | Maintaining compliance during product manufacturing and marketing |
| Core Activities | Submissions of IND, NDA, ANDA, labelling, and product registration | Audits, inspections, SOP monitoring, documentation, CAPA |
| Interactions | Regulatory authorities (FDA, EMA, CDSCO) | Internal teams and auditors, sometimes regulators, during inspections |
| Work Environment | Office based | On-site monitoring, training, and quality system oversight |
| Skills Required | Knowledge of global regulatory submissions, documentation, and communication | Understanding of GMP, GCP, auditing, and risk management |
| Common Job Roles | Regulatory Affairs AssociateRegulatory SpecialistRegulatory Manager | Compliance OfficerQuality Compliance SpecialistAudit Manager |
| Career Goal | Bringing new products to market legally | Ensuring company-wide regulatory integrity |
| Abroad opportunity | Yes | Yes |
Overview
Regulatory Affairs and Regulatory Compliance are both essential pillars of the pharmaceutical and healthcare industry that safeguard patient safety, uphold ethical practices, and ensure product quality. Whether you choose Regulatory Affairs or Regulatory Compliance, a well-structured Regulatory Affairs course by CareerInPharma, which is an industry-oriented, knowledge and skill-based course, can open doors to a rewarding, respected, and globally relevant career for you.
FAQs about Regulatory Affairs Vs Regulatory Compliance
1. Is Regulatory Compliance part of Regulatory Affairs?
Yes, Regulatory Compliance is often considered a subset part or support function within Regulatory Affairs. However, in large organisations, it may operate as a separate department focusing on audits, quality systems, and adherence to regulatory guidelines.
2. What is the difference between Regulatory Compliance and Regulatory Operations?
Regulatory Compliance ensures that the company follows laws and quality standards (like GMP, GCP, GVP), while Regulatory Operations handles the technical side of regulatory submissions, including dossier compilation and eCTD publishing.
3. What qualifications are needed for a career in Regulatory Affairs or Regulatory Compliance?
Any graduates with a degree in pharmacy, life sciences, biotechnology, or medicine can enter these fields. Specialised certifications or diploma courses in Regulatory Affairs offered by CareerInPharma greatly enhance job prospects.
4. What are the common job roles in Regulatory Affairs and Regulatory Compliance?
- Regulatory Affairs: Regulatory Associate, Regulatory Specialist, Regulatory Manager
- Regulatory Compliance: Compliance Officer, QA/Compliance Specialist, Quality Compliance Manager
5. Which career offers better growth—Regulatory Affairs or Regulatory Compliance?
Both offer excellent career growth and global opportunities. Regulatory Affairs professionals often move toward strategic and managerial roles, while Regulatory Compliance experts advance into Quality Management and Global Audit Leadership positions.
6. Are Regulatory Affairs and Regulatory Compliance roles available in remote settings?
Yes. Many MNCs and pharmaceutical companies offer remote or hybrid opportunities in both fields.
7. How much can I earn in Regulatory Affairs or Regulatory Compliance in India?
Entry-level salaries typically range from ₹4 to ₹8 LPA, while experienced professionals can earn ₹8–17 LPA or higher, depending on expertise and the company’s scale.
8. What skills are most valued in these roles?
Skills such as strong documentation, understanding of global submission guidelines, and communication skills, Knowledge of ICH-GCP standards, auditing, risk management, and attention to detail are valued in both fields.
