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- Tasks: Support regulatory aspects of clinical studies and manage serious breach administration tasks.
- Company: Dynamic global company focused on quality and care for its people.
- Benefits: Collaborative environment, career growth, and a chance to make a real impact.
- Other info: Flexible and supportive team with opportunities for professional development.
- Why this job: Join a passionate team changing lives through innovative pharmaceutical projects.
- Qualifications: Degree or equivalent experience in the CRO or pharmaceutical industry.
The predicted salary is between 30000 - 40000 £ per year.
We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 3,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
Join our team of experts, providing support in all regulatory aspects of clinical studies. You will be part of a dedicated team committed to quality and timelines, ensuring the smooth initiation and conduct of projects involving novel pharmaceutical products.
We are currently seeking someone who will take ownership of serious breach administration tasks within the regulatory framework and support clinical study submissions, approvals, and compliance activities specific to the United Kingdom.
You will:
- Support PSI's global serious breach group by documenting, filing and tracking potential cases of serious breaches of GCP, applicable regulations and/or the approved trial protocol.
- Track regulatory project documentation flow and progress reporting.
- Liaise with project team to procure documents necessary for regulatory and ethics committee submissions, ensuring these meet local requirements.
- Prepare submission dossiers within planned timelines and submit to the authority and ethics committee.
- Review investigational product release-enabling documents.
- Maintain regulatory study lifecycle, manage changes in the study as applicable (by means of submitting notifications/supplemental applications).
- Deliver regulatory training to project teams.
- Assist with feasibility research and business development requests, if requested.
- Manage safety reporting to authorities.
Qualifications:
- College/University degree or an equivalent combination of education, training and experience.
- Minimum of 1 year of prior industry experience within the CRO or pharmaceutical industry.
- Understanding of requirement to adhere to the Clinical Trial Regulations.
- Strong organizational skills with the ability to manage multiple projects simultaneously.
- Excellent time management skills and ability to meet tight deadlines.
- Ability to interpret and apply complex regulatory guidelines.
- Communication, collaboration, and problem-solving skills.
At PSI, we create an environment where adapting, evolving, and improving processes comes naturally. Our Regulatory team is highly responsive, supportive, and flexible, always working to deliver a standout service experience for both internal and external customers.
Regulatory Officer in Oxford employer: PSI CRO
Contact Detail:
PSI CRO Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Officer in Oxford
✨Tip Number 1
Network like a pro! Reach out to current or former employees on LinkedIn and ask about their experiences. A friendly chat can give you insider info and might even lead to a referral.
✨Tip Number 2
Prepare for the interview by researching the company’s values and recent projects. Show us that you’re not just interested in any job, but specifically in how you can contribute to PSI’s mission of changing lives.
✨Tip Number 3
Practice your answers to common interview questions, especially those related to regulatory compliance and project management. We want to see that you can handle the pressure and think on your feet!
✨Tip Number 4
Don’t forget to follow up after your interview! A quick thank-you email can keep you fresh in our minds and shows that you’re genuinely interested in the role.
We think you need these skills to ace Regulatory Officer in Oxford
Some tips for your application 🫡
Show Your Passion: When writing your application, let your enthusiasm for the role shine through! We want to see how your skills and experiences align with our mission of changing lives through medical science.
Tailor Your CV: Make sure to customise your CV for the Regulatory Officer position. Highlight relevant experience in regulatory compliance and project management, as we’re looking for someone who can hit the ground running!
Be Clear and Concise: Keep your application straightforward and to the point. We appreciate clarity, so avoid jargon and make it easy for us to see why you’re a great fit for our team.
Apply Through Our Website: Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for this exciting opportunity.
How to prepare for a job interview at PSI CRO
✨Know Your Regulations
Make sure you brush up on the Clinical Trial Regulations and any relevant guidelines. Being able to discuss these confidently will show that you understand the regulatory landscape and are ready to take ownership of serious breach administration tasks.
✨Showcase Your Organisational Skills
Prepare examples from your past experiences where you successfully managed multiple projects or tight deadlines. This will demonstrate your strong organisational skills, which are crucial for tracking regulatory project documentation and ensuring timely submissions.
✨Communicate Clearly
Practice articulating your thoughts clearly and concisely. Since the role involves liaising with project teams and delivering regulatory training, effective communication is key. Consider doing mock interviews with a friend to refine your delivery.
✨Be Ready to Problem-Solve
Think of scenarios where you faced challenges in previous roles and how you overcame them. This will highlight your problem-solving skills, which are essential for navigating complex regulatory guidelines and ensuring compliance.