At a Glance
- Tasks: Lead regulatory activities for innovative oncology therapies and drive Clinical Trial Applications across Europe.
- Company: Global biopharmaceutical leader focused on cutting-edge therapies.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Join a fast-paced, collaborative environment with excellent career advancement potential.
- Why this job: Make a real impact in advancing cancer treatments while collaborating with global experts.
- Qualifications: Proven experience in Regulatory Affairs and strong knowledge of EU regulations.
The predicted salary is between 60000 - 80000 £ per year.
An exciting opportunity has arisen for an experienced Regulatory Affairs Manager to support innovative oncology and advanced therapy programmes within a global biopharmaceutical environment.
This role will play a key part in driving regulatory strategy, leading Clinical Trial Applications (CTA), EU CTR submissions, substantial amendments, and broader regulatory activities across EU.
Working closely with global and regional stakeholders, you will support the development of cutting-edge therapies in a fast-paced, highly collaborative setting.
Key Responsibilities Lead regulatory affairs activities for development-stage and marketed products.
Drive CTA submissions, amendments and EU CTR activities across Europe.
Develop and execute regulatory strategy in partnership with global regulatory teams.
Prepare and coordinate regulatory submissions in line with EU and ICH requirements.
Represent Regulatory Affairs within cross-functional project teams.
Monitor evolving European regulatory requirements and provide strategic guidance to stakeholders.
Experience Required Proven experience within Regulatory Affairs in the pharmaceutical or biotech sector.
Strong knowledge of Clinical Trial Applications (CTA) and the EU Clinical Trials Regulation (EU CTR).
Experience developing and executing regulatory strategy for clinical development programmes.
Broad understanding of European regulatory requirements and procedures.
Experience supporting inter...
Regulatory Affairs Manager Oncology CTA employer: Hays Life Sciences
Join a leading healthcare organisation that values innovation and collaboration, offering a dynamic work environment where you can take ownership of life cycle strategy across a diverse EU portfolio. With flexible working options and a strong focus on employee growth, this company fosters a culture of continuous improvement and support, making it an excellent employer for those looking to make a meaningful impact in regulatory affairs.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Manager Oncology CTA
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Hays Life Sciences. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Hays Life Sciences.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Hays Life Sciences. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
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 Hays Life Sciences is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Regulatory Affairs Manager Oncology CTA
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 Hays Life Sciences!
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 Hays Life Sciences 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 Hays Life Sciences!
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 Hays Life Sciences, 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 Hays Life Sciences
✨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 Hays Life Sciences 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 Hays Life Sciences’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.
