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For people who like the difficult questions.
Regulatory work rewards people who read carefully, think precisely and are willing to say when something is wrong. If that describes you, we should talk.
Why join
The combination is the point
Plenty of firms will give you regulatory depth. Plenty of others will give you interesting technology. The two together, on the same problem, is less common than it should be.
Our work sits where regulatory judgment meets operating models and applied technology. A labelling specialist here is expected to have an opinion about how the process should be automated. Someone building automation is expected to understand why a variation is classified the way it is.
That means the learning curve is real, and we would rather say so. It also means the work stays interesting well past the point where a narrower role would have become routine.
How we work
What to expect
Standards over hours
Regulatory work has to be right. We would rather a deliverable took longer and was correct than shipped on time and generated questions later.
Say when something is wrong
An organisation where people do not raise problems is a compliance risk. Disagreement is expected, including with clients and including upwards.
Close to the client
We work inside client teams. That means more context, more responsibility and more direct exposure to the decisions than a purely back-office role gives.
Deliberate development
Regulatory landscapes change constantly. Time for learning is planned into how we staff work rather than left to evenings and goodwill.
Open roles
Where we are usually hiring
Specific vacancies are posted here as they open. These are the disciplines we recruit into.
Regulatory affairs specialists and leads
Strategy, CMC, lifecycle management and submissions, across pharmaceutical, biologics and device experience.
Labelling specialists
Core data sheet and regional product information experience, labelling change control, and review practice.
Regulatory technology and data
RIM implementation, structured content, data migration and automation in validated environments.
Quality and compliance
Quality systems, computerised system validation, data integrity and audit readiness.
Application process
What happens after you apply
We read it properly
Applications are reviewed by someone who understands the work, not filtered on keywords. You will get an answer either way.
An initial conversation
A discussion about your experience and what you want next. As much about whether we suit you as the reverse.
A technical discussion
A real problem from the kind of work you would be doing. No puzzles unrelated to the job.
Meet the team
Time with the people you would work alongside, and space to ask the questions you would rather not ask a hiring manager.
Open applications
No suitable role listed?
We would still rather hear from strong people than not. Tell us what you do and what you want to be doing in two years.