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