Regulatory Affairs Executive

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