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Agile Management in Regulatory Affairs

All levels
24 lessons
0 quizzes
400 students


  • Willingness to dive into harnessing pharmaceutical and biotechnology industries.
  • Problem-solving and analytical thinking skills.
  • Intermediate level of English and higher, good Internet connection.
  • Ability to manage multiple tasks and deadlines.


  • Coverage of Pharmaceutical Regulatory Frameworks. Explore the ins and outs of pharmaceutical regulations, including guidelines from major agencies like the FDA and EMA. You will get a clear understanding of what it takes to navigate these rules and ensure your products meet all the necessary standards, no matter where in the world you're operating.
  • Integration of Project Management Principles with Regulatory Compliance. Learn how to seamlessly integrate project management methodologies with regulatory compliance requirements to ensure adherence to industry standards throughout the product lifecycle.
  • Strategic Planning and Risk Management. Develop strategic planning skills to anticipate regulatory challenges and mitigate risks effectively, ensuring smooth project execution and compliance with regulatory guidelines.
  • Regulatory Submissions and Documentation Management. Explore preparation and submission of regulatory documents, including INDs (Investigational New Drug applications), NDAs (New Drug Applications), BLAs (Biologics License Applications), and other relevant submissions, while mastering effective documentation management practices.
  • Cross-functional Collaboration and Stakeholder Engagement. Understand the importance of cross-functional collaboration and stakeholder engagement in regulatory projects, including interactions with regulatory authorities, internal teams, external partners, and other stakeholders to facilitate project success.
  • Regulatory Project Lifecycle Management. Explore the regulatory project lifecycle from preclinical development to post-market surveillance, learning how to effectively manage timelines, milestones, and deliverables at each stage while ensuring compliance with regulatory requirements.
  • Case Studies and Practical Applications
  • 200 LAI credits, 3 CECs
  • Research Scientist Title
  • Academy membership
  • Postgraduate Certificate
  • Mobile access
  • Downloadable handy resources
  • Full lifetime access
  • Language: English

Target audiences

  • This course is designed for project managers across all levels, from entry-level to seasoned professionals. It also caters to non-project managers in regulatory affairs, clinical development, clinical operations, medical affairs, clinical pharmacology, and biostatistics.

This course focuses on the practical application of agile management principles in the regulatory affairs of pharmaceutical and biotechnology industries. With a 20% theoretical foundation and 80% practical guidance, you’ll gain a deep understanding of real-world scenarios faced by development project managers.
This course delves into current issues within regulatory affairs in the pharmaceutical industry. Given the dynamic nature of regulatory landscapes, there is often no unanimous agreement on the best approach to handling these matters, nor is it likely that consensus will be reached. However, what we offer here is a comprehensive synthesis of industry insights, providing aligned recommendations for navigating these challenges within management and biopharmaceutical regulation.

Course Benefits:
– Enhances your agile management skills and knowledge to manage complex pharmaceutical projects effectively.

– Develops strategies for building efficient and effective team structures and environments.

– Addresses the challenges project managers encounter in pharmaceutical development and find solutions.

– Makes a valuable asset to your team and contributes significantly to the success of pharmaceutical projects.

This course was prepared by Linda Pelosi, with the guidance of Ladavius Dean, Ellen Shokalo, who are delighted to share knowledge and expertise in the pharmaceutical industry with our members — aspiring professionals like you.

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📚 Passionate Academy Lecturer | Clinical Development Industry Specialist | EMA Advisor | GRIDALL MBA Model Tutor | Coach | 26 years of global project management experience | Regulatory and Medical Writing