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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 with a supportive and collaborative culture.
- Benefits: Gain broad regulatory exposure and develop into a senior role.
- Why this job: Take ownership in a fast-paced environment and make a real impact.
- Qualifications: Regulatory Affairs experience and strong communication skills required.
- Other info: Opportunity for continuous improvement and career growth.
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 Officer, 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. 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
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 for a confidential discussion.
Regulatory Affairs Officer in Northolt employer: Smart4Sciences
Contact Detail:
Smart4Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Officer in Northolt
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of MHRA processes and recent regulatory changes. We recommend practising common interview questions with a friend to boost your confidence and ensure you shine during the real deal.
✨Tip Number 3
Showcase your problem-solving skills! During interviews, share specific examples of how you've tackled complex licensing scenarios. We want to see how you think on your feet and handle challenges in a fast-paced environment.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to connect directly with us.
We think you need these skills to ace Regulatory Affairs Officer in Northolt
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Officer 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 background makes you a great fit for our team. Keep it concise but impactful – we love a good story!
Showcase Your Attention to Detail: As a regulatory professional, attention to detail is key. Make sure your application is free from typos and errors. We appreciate candidates who take the time to ensure their submissions are polished and professional.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the easiest way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen to join our team at StudySmarter!
How to prepare for a job interview at Smart4Sciences
✨Know Your Regulations
Make sure you brush up on the latest MHRA guidelines and regulations. Being able to discuss specific licensing scenarios and demonstrate your understanding of PLPI applications will show that you're not just familiar with the basics, but that you’re ready to tackle complex issues head-on.
✨Showcase Your Problem-Solving Skills
Prepare examples from your past experiences where you've successfully resolved regulatory challenges. This could be anything from managing RFIs to ensuring first-time approvals. Highlighting your proactive approach will resonate well with the interviewers.
✨Communicate Clearly and Confidently
Since strong communication skills are essential for this role, practice articulating your thoughts clearly. Use concise language when discussing your experience with regulatory documentation and stakeholder management to convey confidence and professionalism.
✨Demonstrate Your Organisational Skills
Be ready to discuss how you manage your portfolio of licences and keep track of regulatory changes. Sharing your methods for maintaining accurate records and updates will illustrate your attention to detail and organisational prowess, which are crucial for a Regulatory Affairs Officer.
