Demonstrate your regulatory competence
TOPRA has been approved by the Science Council as an awarding body for Registered Scientist (RSci).
What is Registered Scientist?
Registered Scientist is a professional registration that recognises your competence on-the-job independent of discipline. It provides recognition for professional practice and experience and thus complements the academic qualifications you might also have.
Typically, professionals need to have been working for two years to achieve this and must either have a Foundation Degree qualification or equivalent (QCF Level 5) or be able to demonstrate that they are working at this level.
Registered scientist can provide a stepping stone on the journey to Chartered Scientist. It allows you to gain recognition for the work you do and the knowledge and skills you have.
Your registration will be based on your regulatory affairs experience but other scientists in other disciplines can also gain registration as a Registered Scientist. This allows you to show that you are equivalent to other people working in other aspects of drug or device development. It is based on 16 broad scientific competencies and to apply you need to demonstrate and evidence how you meet all these competencies in your daily work.
Applying for Registered Scientist Status
The process and requirements for applying for Registered Scientist are set out in the guidance document below. To apply for Registered Scientist, you will need to complete the application form (link below). For each competence you need to demonstrate that you meet the criteria set out in the Matrix of Competency Descriptions
. The Matrix also provides some suggestions of possible examples you might use.
To support your application you need to provide the details of one supporter. Your supporter should be a senior colleague who is familiar with your work, typically a line manager or supervisor. Wherever possible they should be a TOPRA member and a Registered or Chartered Scientist. Once you have provided their details we will contact them to obtain their input. Please make sure they are aware that you are applying and are expecting to hear from us.
If you do not have a suitable degree level qualification in a scientific or engineering subject you will need to complete the RSci equivalence report.
For Registered Scientist you need a qualification that is the equivalent of the second year of a three year bachelor’s degree, this is level 5 in England, Wales or Northern Ireland and a level 8 qualification in Scotland. Examples include a Foundation Degree, HND, Diploma of Higher Education, or a Scottish Higher National Diploma or Advanced Diploma. If you have a bachelor’s degree this is more than sufficient.
The equivalence report is designed to capture evidence that you have developed the necessary scientific competencies and how you have developed these. This is likely to be a mixture of training, self-study, on the job experience and other professional development activities. Please refer to the RSci equivalence report which contains additional guidance within it.
Finally you will need to pay the application fee.
Step 1: Complete the application form
Step 2: Pay the application fee
Step 3: Send your application to us at firstname.lastname@example.org
Step 4: We will contact your supporter with a copy of your application form and ask them to complete the supporters form.
Step 5: Your application and the responses from your supporter will be submitted to the assessment panel who meet every quarter. The assessment panel make a recommendation to the Board, once they have ratified your registration we will contact you with the result. This can take up to eight weeks.
Download our guidance document: RSci Application Guidance
- Q1: 1 February
- Q2: 5 April
- Q3: 5 July
- Q4: 4 October
Maintaining your Registered Scientist status
To maintain your Registered Scientist status you will need to maintain your TOPRA membership, pay an annual Registered Scientist subscription fee and demonstrate that you meet the Continuing Professional Development (Lifelong Learning) requirements by submitting your CPD records using our online CPD tool
. Please refer to the Frequently Asked Questions
to see further information about the CPD requirements that Registered Scientists must meet.
Code of Conduct
The TOPRA Statement of Values is the code of conduct all professionally registered members are required to follow and agree to be bound by.
There is also a Disciplinary Procedure for TOPRA members holding professional registration.
Anyone who has concerns, or a complaint about, a Chartered Scientist working in regulatory affairs who is registered through TOPRA, should refer to TOPRA’s complaints policy.