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Regulatory Affairs Executive
Job Posted: an hour ago
Salary: £ 40,000 - 50,000 / Annum
Job Type: Permanent
Location: LL13, Pentre Maelor, Wrexham
Expire in: a month
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 desirableBefore You Apply
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Looking for your next career move? Join a top company hiring Regulatory Affairs Executive job near me in LL13, Pentre Maelor, Wrexham! This is your chance to work on exciting projects, grow professionally, and enjoy a rewarding career with competitive pay and excellent benefits. Whether you're an experienced professional or looking to take the next step, this role offers the perfect opportunity to enhance your skills and make an impact. Don’t miss out—apply today via Vita CV and take your career to the next level!
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