Certification in Regulatory Affairs

3 Hours
All levels
0 lessons
1 quiz
599 students


  • It is recommended to review Dossier Structure, History of the Regulatory Affairs, Quality and Compliance, FDA, EMA regulatory frameworks before attempting the examination.
  • Basic level of English, good quality Internet connection.


  • 3 hours, 44 questions
  • 200 LAI credits
  • Academy membership
  • Mobile access
  • Research Scientist Title
  • Postgraduate Certificate
  • Single-choice, multiple-choice questions
  • Language: English

Target audiences

  • Regulatory Affairs Associates, Specialists
  • Regulatory Affairs Managers
  • Quality Specialists
  • Graduates, Postgraduates, PhD. Students

The Certification in Regulatory Affairs program is a comprehensive assessment designed to confirm a candidate’s deep knowledge and proficiency in Regulatory Affairs. This certification serves as a testament to the individual’s understanding and mastery of the Regulatory Affairs Compliance.

Program Overview:

  • Depth of Knowledge: The program encompasses a wide array of topics crucial to Regulatory Affairs, including but not limited to regulatory processes, compliance strategies, quality assurance, and global regulatory frameworks.
  • Interactive Learning Approach: Candidates engage in a unique learning experience where questions are supplemented with expansive “Hint” and “Explanation” sections filled with valuable knowledge and resources. This approach fosters a deeper understanding of the subject matter while providing practical insights into real-world scenarios.
  • Comprehensive Assessment: The certification consists of 44 questions meticulously designed to evaluate the candidate’s comprehension and application of regulatory principles. Candidates have a timeframe of 3 hours to complete the examination.
  • Postgraduate Regulatory Affairs Certificate: Upon successfully answering 80% of the test questions, candidates are awarded a Postgraduate Certificate in Regulatory Affairs, recognizing their dedication and expertise in the field.

Additional Benefits:

  • Opportunity for Improvement: The program allows candidates up to 5 re-takes of the certification examination, providing ample opportunities to reinforce learning and enhance performance.
  • Guidance and Support: For candidates facing challenges or seeking clarification on specific topics, it is recommended to consult with a Learning Consultant at least before the last examination re-take. These experts can offer personalized guidance to address gaps in knowledge and optimize the learning experience.

The Certification in Regulatory Affairs program offers a rigorous yet rewarding path for professionals aspiring to excel in the field of Regulatory Affairs. By earning this certification, candidates demonstrate not only their theoretical understanding but also their ability to navigate and adapt to the ever-evolving regulatory landscape with confidence and competence.

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Master of Science. Several years of efficient development regulatory strategies, documents and process improvements in regulatory affairs and clinical trials. As Regulatory Affairs professional (GLOBAL) - had experience in registration of original biological products, generics, veterinary products in 27 countries around the world (EMEA, LATAM, ASEAN, MENA, Africa, CIS...). Member of regulatory committee CoVIg-19 Plasma Alliance, which has accelerated the development of a treatment to fight COVID-19. Regulatory Affairs Professional Society Member and RAPS certificate holder. Was part of IQVIA - Clinical Trial Regulatory Management Team, global.
Currently working at Eli Lilly and Co. - Global Business Solutions, Cork, Ireland on clinical trials launching, regulatory submissions, including EU CTR.