At a Glance
- Tasks: Support regulatory activities for innovative oncology medicines and ensure compliance with UK regulations.
- Company: Ipsen Ltd, a global biopharmaceutical company focused on transformative medicines.
- Benefits: Hybrid working, inclusive culture, and opportunities for personal and professional growth.
- Other info: Join a passionate team dedicated to improving patient outcomes and fostering innovation.
- Why this job: Make a real impact on patients' lives while working in a dynamic and collaborative environment.
- Qualifications: Degree in Life Sciences and experience in the pharmaceutical industry required.
The predicted salary is between 63000 - 77000 £ per year.
- Title: Regulatory Affairs Officer
- Company: Ipsen Ltd
- About
Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience.
Supported by nearly 100 years of development experience, with global hubs in the U.
S., France and the U.
K, we tackle areas of high unmet medical need through research and innovation.
Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries.
We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact.
At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success.
Join us on our journey towards sustainable growth, creating real impact on patients and society!
For more information, visit us at and follow our latest news on Linked In and Instagram.
Job Description: Regulatory Affairs Officer
- Department: Medical & Regulatory Affairs, UK & Ireland
- About
Ipsen: At Ipsen, we are committed to improving the lives of patients through innovative medicines in areas of significant unmet need.
Whilst this role will work across all Ipsen products, oncology is a key strategic focus, and this role offers the opportunity to support a portfolio of established and emerging oncology therapies that make a meaningful difference to patients across the UK and Ireland.
Key Responsibilities
- Regulatory Affairs Support the preparation and submission of regulatory lifecycle maintenance activities in the UK and Ireland.
- Coordinate and implement approved regulatory changes, including updates to Sm PCs, PILs, labels and packaging materials.
- Support responses to requests from regulatory authorities, including the MHRA and HPRA.
- Maintain regulatory databases, submission trackers and document management systems.
- Work closely with Global Regulatory Affairs and cross-functional stakeholders to support regulatory strategy and execution.
- Contribute to licence maintenance and optimisation activities across Ipsen's oncology and specialty care portfolio.
- Regulatory Intelligence Monitor and communicate developments within the UK and Irish regulatory environment.
- Conduct competitor intelligence activities and monitor regulatory developments within oncology.
- Support the assessment of regulatory changes that may impact the business and patients.
- Compliance & Quality Ensure all activities are conducted in accordance with applicable regulatory requirements, Gx P standards and company procedures.
- Support controlled document management and quality systems activities.
- Assist with change controls, deviations, CAPAs and inspection readiness initiatives.
- Support complaint administration and investigation activities as required.
- Contribute to compliance reporting and KPI generation.
- Cross-Functional Collaboration Partner with colleagues across Medical Affairs, Pharmacovigilance, Quality, Supply Chain, Commercial and Global Regulatory Affairs teams.
- Support continuous improvement initiatives within the Regulatory Affairs and Quality function.
- Help maintain a culture of compliance, quality and patient focus.
Essential Requirements
- Degree in Life Sciences or a related scientific discipline.
- Experience working within the pharmaceutical industry.
- Understanding of the UK medicines regulatory framework.
- Basic knowledge of Gx P requirements.
- Strong organisational and project management skills.
- Excellent written and verbal communication skills.
- Ability to manage multiple priorities and work to tight deadlines.
- Strong attention to detail and commitment to quality.
Desirable
- Experience supporting MHRA submissions.
- Experience with Regulatory Operations activities.
- Experience working with Quality Management Systems.
- Knowledge of quality processes, including deviations, CAPAs and change controls.
- TOPRA membership or working towards membership.
- Previous experience supporting oncology products.
What We're Looking For
The successful candidate will be a proactive, collaborative and detail-oriented regulatory professional who enjoys working in a fast-paced environment.
You will be comfortable building relationships across functions, managing competing priorities and ensuring activities are delivered to a high standard.
Most importantly, you will be motivated by the opportunity to support innovative oncology medicines and contribute to improving outcomes for patients.
We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace "The Real Us".
The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities.
When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions.
Together we strive to better understand the communities we serve.
This means we also want to help you perform at your best when applying for a role with us.
If you require any adjustments or support during the application process, please let the recruitment team know.
This information will be handled with care and will not affect the outcome of your application.
At Ipsen, each employee makes a real impact.
Our teams are passionate about what they do because they care about making a difference in patients' lives.
We invest in our employees to support life-changing projects that create positive impact for patients and society.
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Regulatory Affairs Officer in London employer: Ipsen Ltd
Ipsen Ltd is an exceptional employer that prioritises employee growth and well-being, fostering a culture of collaboration and innovation. With a commitment to transforming rare disease care, employees are empowered to make a meaningful impact while enjoying a supportive work environment that values diverse perspectives. Located in the UK, Ipsen offers unique opportunities to engage with NHS organisations and contribute to healthcare transformation, ensuring that every team member can thrive alongside the company's mission to improve patient outcomes.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Officer in London
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When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Ipsen Ltd is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Regulatory Affairs Officer in London
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Ipsen Ltd!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Ipsen Ltd that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Ipsen Ltd!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Ipsen Ltd, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Ipsen Ltd
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Ipsen Ltd that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Ipsen Ltd’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
