The Module
This module is designed for regulatory affairs professionals to develop and deepen their understanding of the regulatory operations and authorisation procedures in the United States. It allows students to analyse and critically evaluate the US regulatory framework and the role of the FDA in drug development. Students will explore the legal and practical requirements for drug approval in the US, with case studies supporting real-world application.
Key topics include:
US regulatory landscape and drug development history
IND, NDA, ANDA, BLA and sNDA pathways
Orphan drugs, OTC products, fast-track designations
Regulatory documentation, advertising, labelling, and adverse event reporting
Interactions and communication with the FDA
The module includes lectures, workshops and case studies. It is part of the MSc and Apprenticeship programmes and is delivered face-to-face in London, at the TOPRA Office.
Key Responsibilities
As Module Leader, you will:
Develop and finalise the module programme in line with approved learning outcomes
Identify, invite and brief expert speakers (with administrative support from TOPRA)
Ensure content meets the academic and professional standards required by the MSc
Chair or co-chair the delivery of the module over the 2.5 days
Prepare reading lists and oversee the development of case studies and assessment questions
Provide a brief end-of-module report to support evaluation and continuous improvement
Requirements
Essential:
Substantial experience in US regulatory affairs or global development with a US focus
Involvement in training, mentoring, or developing others in the profession
Comfortable working collaboratively and engaging expert speakers
Member or Fellow of TOPRA
Desirable:
Experience working with universities or delivering academic/CPD content
Familiarity with MSc-level assessment and learning outcomes
Experience facilitating or chairing professional development events
What You Gain
Recognition within the regulatory affairs community as a TOPRA Module Leader
Opportunity to help shape the learning experience for MSc students
Direct engagement with the next generation of regulatory professionals
Collaboration with an experienced academic and professional support team
Travel and accommodation expenses covered in line with TOPRA's expenses policy
Location
Planning: Remote
Module delivery: In-person, in London at the TOPRA office.
Remuneration
This is a volunteering opportunity; however, we will pay expenses (wholly incurred in performing these duties) in accordance with TOPRA's expenses policy.
Interested?
This is a voluntary position supported by TOPRA’s professional development team.
To express your interest or recommend a colleague, please contact: Rosely Solomon, Head of Training and Qualifications -
rosely.solomon@topra.org
Course(s):
Successfully Navigating European Regulatory Procedures (21 -22 July 2026)
CRED Understanding Clinical Development ( 13-14 October 2026)
Requirements:
5 - 10 years of experience required in the subject area
Individuals with knowledge of the EU or UK regulatory affairs are welcome to apply.
Responsibilities:
Work with working party to review the course programme and provide relevant input
Review case study materials and presentations alongside working party members
Assist working party to source presenters/speakers for the event
Time commitment
Bi-weekly online meetings (based on availability)
Location
Meetings to be held online, however, the event will take place in-person/online.
How to apply
Send your CV outlining your experience to meetings@topra.org.
We currently do not have any vacancies for new speakers at any of our training courses, however we are always looking for new speakers for potential future courses.
If you would like to become a training course speaker, please express your interest by contacting meetings@topra.org.