LICQual Level 6 Diploma in Pharmaceutical Regulatory Affairs
Medicines save lives, but their journey from laboratory to patient is tightly controlled to ensure safety, quality, and effectiveness. Every drug must pass through a complex system of approvals, compliance checks, and international standards before reaching the market. This is where pharmaceutical regulatory affairs play a critical role. Without strong regulatory frameworks, healthcare systems risk unsafe products, inconsistent standards, and reduced public trust.
The LICQual Level 6 Diploma in Pharmaceutical Regulatory Affairs (D Regulatory Affairs) highlights the importance of this discipline in modern healthcare. Pharmaceutical regulatory affairs are not simply about paperwork—they are about safeguarding lives, ensuring transparency, and guiding innovation responsibly. As new therapies, biologics, and advanced technologies emerge, professionals trained in this area are essential for bridging science with law, and industry with patient safety. For learners, engaging with this subject is more than academic—it is an opportunity to influence global healthcare, strengthen pharmaceutical standards, and play a pivotal role in shaping the future of medicine through compliance and regulation.p.
Program Outline
The LICQual Level 6 Diploma in Pharmaceutical Regulatory Affairs (D Regulatory Affairs) is a structured qualification designed to provide learners with advanced knowledge of compliance and regulation in pharmaceutical practice. Comprising 6 specialized units and worth 120 credits, the program introduces learners to areas such as international regulatory frameworks, quality assurance, compliance management, ethical considerations, documentation processes, and healthcare policy in pharmaceutical regulatory affairs.
This section explains how the course equips learners with the ability to understand pharmaceutical regulatory affairs, apply evidence‑based approaches, and align with global standards effectively. It highlights the type of learners the program is aimed at, the skills they will gain, and the career pathways available upon completion. Readers will also discover how this internationally recognized qualification opens opportunities in hospitals, pharmaceutical companies, government agencies, and research institutions, making it a valuable credential for anyone aspiring to build a career in pharmaceutical regulatory affairs.
Unit Structure
| Qualification | Unit Title | Credits | GLH |
| LICQ2201194-1 | Introduction to Pharmaceutical Regulatory Affairs | 20 | 80 |
| LICQ2201194-2 | Medicines Legislation and Compliance | 20 | 80 |
| LICQ2201194-3 | Regulatory Documentation and Submission Processes | 20 | 80 |
| LICQ2201194-4 | Pharmacovigilance and Risk Management | 20 | 80 |
| LICQ2201194-5 | Clinical Trials and Regulatory Strategy | 20 | 80 |
| LICQ2201194-6 | Advanced Regulatory Affairs Project | 20 | 80 |
Who Can Benefit
The LICQual Level 6 Diploma in Pharmaceutical Regulatory Affairs (D Regulatory Affairs) is designed for individuals who want to specialize in compliance, regulation, and policy within the pharmaceutical sector. This program is particularly valuable for those who aim to address challenges such as product safety, documentation accuracy, and adherence to international standards. It helps learners strengthen their expertise, improve employability, and prepare for roles where pharmaceutical regulatory affairs are central to healthcare delivery.
Ideal Learners
- Students aspiring to enter pharmaceutical sciences with a focus on regulation.
- Entry‑level professionals seeking structured training in pharmaceutical regulatory affairs.
- Pharmacy assistants wanting to expand knowledge of compliance and documentation.
- Community pharmacy staff preparing for responsibilities in regulatory frameworks.
- Hospital pharmacy technicians aiming to strengthen skills in quality assurance.
- Healthcare professionals transitioning into pharmaceutical regulatory affairs roles.
- Career changers interested in pharmaceutical law and compliance.
- Ambitious learners who want to develop practical skills for pharmaceutical regulatory affairs careers.
What You’ll Be Able to Do
Unit 1: Introduction to Pharmaceutical Regulatory Affairs
By the end of this unit, learners will be able to:
- Explain the role and scope of regulatory affairs in the pharmaceutical industry
- Analyse national and international regulatory frameworks for medicines and healthcare products
- Evaluate the impact of regulations on drug development and market authorisation
- Apply regulatory knowledge to support compliance and strategic decision-making
Unit 2: Medicines Legislation and Compliance
By the end of this unit, learners will be able to:
- Demonstrate understanding of national and international medicines legislation
- Evaluate compliance requirements including GMP, GCP, and other industry standards
- Analyse the legal and ethical responsibilities of pharmaceutical organisations
- Apply legislative knowledge to ensure regulatory compliance in practice
Unit 3: Regulatory Documentation and Submission Processes
By the end of this unit, learners will be able to:
- Prepare and review regulatory dossiers and submission documents accurately
- Analyse requirements for marketing authorisation applications and reporting processes
- Evaluate regulatory submission strategies to ensure approval efficiency
- Apply documentation standards to support compliance and product registration
Unit 4: Pharmacovigilance and Risk Management
By the end of this unit, learners will be able to:
- Explain principles and processes of pharmacovigilance and drug safety monitoring
- Analyse adverse event data and implement risk management strategies
- Evaluate regulatory requirements for safety reporting and mitigation plans
- Apply pharmacovigilance procedures to ensure patient safety and regulatory compliance
Unit 5: Clinical Trials and Regulatory Strategy
By the end of this unit, learners will be able to:
- Demonstrate understanding of clinical trial design and regulatory approval processes
- Analyse protocols for compliance with ethical and legal standards
- Evaluate regulatory strategies for product development and lifecycle management
- Apply regulatory knowledge to support effective clinical trial management
Unit 6: Advanced Regulatory Affairs Project
By the end of this unit, learners will be able to:
- Plan and execute an independent project addressing a real-world regulatory challenge
- Critically review scientific and regulatory literature to inform project outcomes
- Develop practical solutions and strategies for regulatory compliance
- Present findings professionally, demonstrating analytical, decision-making, and reporting skills
