Regulatory Affairs Executive

Nexus Life Sciences; Pentre Maelor; Hybrid; GBP 40,000 - 50,000; Full time

Job summary

A leading pharmaceutical manufacturer in North Wales is seeking a Regulatory Affairs Executive to ensure product compliance across various markets. This role features hybrid working with up to 2 days from home. Candidates should have a degree in Life Sciences and experience in regulatory affairs. The position involves preparing regulatory submissions and maintaining compliance with legislation. This is a critical role supporting the manufacturing of sterile injectable products.

Qualifications

• Experience working in Regulatory Affairs within the pharmaceutical industry.
• Understanding of GMP and the pharmaceutical product lifecycle.
• Membership of TOPRA and/or OTC product experience is desirable.

Responsibilities

• Determine regulatory submission requirements and assess documentation.
• Prepare marketing authorisation applications and renewals.
• Ensure dossiers are consistent and complete.
• Respond to regulatory information requests.
• Commission and review artwork for submission accuracy.
• Coordinate submission packages for regulatory authorities.
• Draft SmPCs and Patient Information Leaflets.
• Monitor changes in legislation and regulatory guidance.

Skills

Attention to detail

Organizational skills

Independent workload management

Communication skills

IT competency in regulatory systems

Education

Degree in Life Sciences

Job description

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