Your new company
You will be joining a leading organisation in the pharmaceutical and medical technology sector, specialising in the manufacture of drug-device combination products. The business is recognised for its innovative technologies and its focus on sustainability, working closely with global regulatory bodies and clients.
Your new role
As a Regulatory Manager, you will take on a highly visible, client-facing position, responsible for leading regulatory strategy across drug-device combination product projects. You will provide expert guidance on regulatory pathways, supporting customers in achieving approvals across regions such as the EU and US.
Your role will involve leading regulatory aspects of development projects, reviewing and approving key documentation (including DMFs, technical files, and CTD submissions), and acting as a primary point of contact for regulatory agencies such as the MHRA, EMA, and FDA.
As second in command, you will also play a key leadership role, managing a small team with scope to grow, contributing to regulatory intelligence across the business, and representing the regulatory function in senior-level internal and external meetings.
What you'll need to succeed
To be successful in this role, you will ideally have:
1. Around 10 years of regulatory experience within pharmaceuticals or medical devices
2. Strong experience in drug-device combination product ...