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For Companies At a Glance
- Tasks: Manage UK pharmaceutical licences and ensure compliant submissions to the MHRA.
- Company: Join a growing pharmaceutical group in Manchester with a collaborative culture.
- Benefits: Gain broad regulatory exposure and develop into a senior role.
- Why this job: Take ownership and make an impact in a fast-paced pharmaceutical environment.
- Qualifications: Experience in Regulatory Affairs or Quality within the pharmaceutical industry.
- Other info: Supportive team environment with opportunities for continuous improvement.
The predicted salary is between 36000 - 60000 £ per year.
Smart4 Sciences is partnering with a growing pharmaceutical group to recruit a Regulatory Affairs Executive to support and manage a diverse portfolio of UK licences across parallel import, licensing, and manufacturing operations. This is an excellent opportunity for a regulatory professional with strong MHRA exposure who enjoys ownership, problem-solving, and cross-functional collaboration within a fast-moving pharmaceutical environment.
The Role
As Regulatory Affairs Executive, you will manage a portfolio of licences end-to-end, ensuring compliant, high-quality submissions to the MHRA while acting as a subject-matter expert for complex licensing scenarios. You will also deputise for the Senior Regulatory Officer when required. Key focus areas include PLPI applications, variations, renewals, and ongoing regulatory compliance across multiple business units.
Key Responsibilities
- Manage and maintain your own portfolio of UK pharmaceutical licences
- Prepare, submit, and manage PLPI licence applications, variations, and renewals
- Act as a key point of contact with the MHRA, proactively resolving RFIs and clarifying requirements
- Ensure submissions are approved first time or with a maximum of one RFI
- Maintain accurate regulatory records and updates within internal systems
- Support buyers and internal stakeholders with up-to-date regulatory guidance
- Identify regulatory changes and assess business impact
- Lead or contribute to continuous improvement and process optimisation initiatives
- Project manage regulatory aspects of major legislative or procedural changes
- Deputise for the Senior Regulatory Officer when required
About You
You will be a detail-driven regulatory professional with a strong compliance mindset and a proactive, solutions-focused approach.
Essential:
- Regulatory Affairs or Quality experience within the pharmaceutical industry
- Good working knowledge of GMP
- Experience working with MHRA submissions and regulatory documentation
- Strong written English, grammar, and attention to detail
- Excellent organisational, communication, and stakeholder management skills
- Confident working independently while collaborating cross-functionally
Desirable:
- Degree in a scientific discipline (Pharmaceutical Sciences preferred)
- Experience with parallel import licences (PLPI)
- Exposure to artwork authoring and regulatory labelling
- Quality experience including deviations, complaints, CAPAs, and root cause analysis
- Experience supporting regulatory change or improvement projects
Why Apply?
- Broad regulatory exposure across licensing, PI, and manufacturing
- High level of ownership and responsibility
- Opportunity to develop into a senior regulatory role
- Supportive, collaborative regulatory team environment
To apply or find out more, contact Rezaune Koopman for a confidential discussion.
Regulatory Affairs Executive employer: Smart4Sciences
Contact Detail:
Smart4Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Executive
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. Building connections can lead to insider info about job openings and even referrals.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of MHRA processes and recent regulatory changes. We want you to showcase your expertise and problem-solving skills, so practice answering common interview questions related to compliance and licensing.
✨Tip Number 3
Don’t just apply and wait! Follow up on your applications after a week or two. A quick email expressing your continued interest can keep you on their radar and show your enthusiasm for the role.
✨Tip Number 4
Check out our website for the latest job openings in regulatory affairs. Applying directly through us not only gives you access to exclusive roles but also shows you're serious about joining our team!
We think you need these skills to ace Regulatory Affairs Executive
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Executive role. Highlight your experience with MHRA submissions and any relevant regulatory projects you've worked on. We want to see how your skills match what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how your proactive, solutions-focused approach can benefit our team. Keep it concise but impactful!
Showcase Your Soft Skills: While we love seeing your qualifications, don’t forget to showcase those essential soft skills! Communication, organisation, and collaboration are key in this role, so give us examples of how you've demonstrated these in your previous work.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep everything organised and ensures your application gets the attention it deserves. Plus, it’s super easy!
How to prepare for a job interview at Smart4Sciences
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of MHRA submissions and the specific regulations related to PLPI applications. Being able to discuss these topics confidently will show that you're not just familiar with the basics, but that you truly understand the complexities involved.
✨Showcase Your Problem-Solving Skills
Prepare examples from your past experience where you've successfully navigated regulatory challenges or improved processes. This role requires a proactive approach, so demonstrating your ability to tackle issues head-on will set you apart from other candidates.
✨Communicate Clearly and Effectively
Since this position involves liaising with various stakeholders, practice articulating your thoughts clearly. Use concise language and be ready to explain complex regulatory concepts in a way that's easy to understand. Good communication is key!
✨Demonstrate Your Organisational Skills
Be prepared to discuss how you manage your workload and keep track of multiple licences. Share specific tools or methods you use to stay organised, as this will highlight your attention to detail and ability to handle the demands of the role.
