CV-Library
Regulatory Manager
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:
Around 10 years of regulatory experience within pharmaceuticals or medical devices
Strong experience in drug-device combination product development and successful filings in EU and/or US markets
Proven ability to lead regulatory projects and manage multiple priorities
Excellent communication and stakeholder management skills
A scientific or regulatory degree (or equivalent)
Background in line management
You will also bring strong leadership capabilities, with experience mentoring or managing teams and working cross-functionally within complex environments.
What you'll get in return
In return, you will have the opportunity to work in a strategic, impactful role within a forward-thinking organisation at the forefront of drug-device combination product manufacturing. You will gain exposure to global regulatory projects, senior stakeholders, and cutting-edge developments in sustainable technologies, alongside opportunities to develop your leadership career.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career