Regulatory Affairs Executive – North Wales (Hybrid)
Hours: 8:30am–4:30pm, Monday to Friday
Hybrid: Up to 2 days working from home per week
Salary: £40,000 – £50,000 DOE
Are you a motivated Regulatory Affairs professional with the ability to interpret complex legislation across multiple markets? Do you hold a degree in Life Sciences and have experience working within pharmaceutical regulatory environments?
If so, this could be the perfect next step in your career.
A rare opportunity has arisen for a Regulatory Affairs Executive to join the team of my client, a leading pharmaceutical manufacturer specialising in sterile injectable products for global markets. You’ll play a key role in ensuring our products remain fully compliant and approved across the UK, Ireland and international territories.
What You’ll Be Doing
As a Regulatory Affairs Executive, you will support a broad range of regulatory submissions and ensure all documentation meets the highest standards of accuracy and compliance. Your responsibilities will include:
* Determining regulatory submission requirements and assessing documentation for acceptability
* Preparing and compiling marketing authorisation applications, renewals, variations, and eCTD baselines
* Ensuring dossiers are consistent, clear and complete, resolving any outstanding queries
* Responding to internal and external regulatory information requests
* Commissioning and reviewing artwork for submission accuracy and brand compliance
* Coordinating submission packages for regulatory authorities
* Supporting variation submission strategies
* Liaising and negotiating with regulatory agencies and third-party partners
* Drafting SmPCs and Patient Information Leaflets
* Monitoring changes in legislation and regulatory guidance
* Maintaining regulatory databases and publishing electronic submissions
* Operating in line with departmental and company SOPs
* Representing Regulatory Affairs in internal meetings
* Supporting and contributing to the Pharmaceutical Quality System, including data collection and continuous improvement activities
The Regulatory Affairs Executive will need to have:
* Degree (or equivalent) in a Life Sciences discipline
* Experience working in Regulatory Affairs within the pharmaceutical industry
* Understanding of GMP and the pharmaceutical product lifecycle
* Excellent attention to detail and strong organisational skills
* Ability to manage your own workload independently
* Confident communicator with strong IT competency in regulatory systems
* Membership of TOPRA and/or OTC product experience is desirable