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Regulatory Affairs Manager EU & US

Job Posted: 4 days ago

Salary: £ Competitive
Job Type: Permanent
Location: Cheshire

Expire in: 24 days

Job Description

Your new company

You will be joining a leading CDMO organisation within the pharmaceutical sector, supporting the development and manufacture of complex drug products. The business is recognised for its innovative approach, strong client partnerships, and commitment to sustainability, working closely with global regulatory bodies. They are looking for an experienced regulatory professional to drive regulatory strategy across EU and US activities. 

Your new role

As a Regulatory Manager

Provide strategic regulatory support to the assigned Regulatory Strategy Lead. 
Support EU and US development regulatory activities across ongoing programmes. EU Centralised Procedure Support

Provide strategic support for EMA centralised procedure activities.
Assist with dossier compilation and submission coordination.
Support life cycle management activities associated with development submissions.
Ensure alignment of submission documentation with EU regulatory requirements and timelinesFDA Regulatory Support

Support US regulatory activities and FDA-related documentation requirements.
Assist with submission preparation and document management activities for US filings.
Coordinate responses, updates, and submission components in collaboration with the Regulatory Strategy Lead.
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 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. 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

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