At a Glance
- Tasks: Prepare and submit regulatory dossiers for generic medicinal products, ensuring compliance with MHRA and EMA.
- Company: An established generics pharmaceutical company focused on high-quality, affordable medicines in the UK and EU.
- Benefits: Collaborative team environment and commitment to employee development.
- Other info: Experience with CTD/eCTD submissions and lifecycle management is essential.
- Why this job: Join a research-driven company impacting healthcare through affordable medicines.
- Qualifications: Degree in Life Sciences or Pharmacy and proven Regulatory Affairs experience in pharmaceuticals required.
The predicted salary is between 45000 - 55000 £ per year.
Your new company is an established, research-driven generics pharmaceutical company with a strong presence across the UK and EU markets. The organisation offers a collaborative, team-oriented environment and is committed to delivering high-quality, affordable medicines while supporting employee development.
Your new role involves supporting the lifecycle management of a diverse portfolio of generic medicinal products. You will be responsible for preparing and submitting regulatory dossiers (including MAAs, variations, and renewals) in line with MHRA and EMA requirements, as well as managing post-approval activities. You will liaise with regulatory authorities, respond to queries within agreed timelines, and ensure compliance of product labelling and documentation (SmPCs, PILs, artwork). The role also involves supporting regulatory strategy, tracking submission timelines, and monitoring evolving regulatory guidelines to assess business impact.
What you'll need to succeed:
- Degree in Life Sciences, Pharmacy, or a related field
- Proven Regulatory Affairs experience within the pharmaceutical industry (generics preferred)
- Strong knowledge of UK (MHRA) and EU regulatory frameworks
- Experience with CTD/eCTD submissions and lifecycle management
- Familiarity with variations and post-approval processes
- Excellent organisational and communication skills
- Ability to manage multiple projects in a fast-paced environment
Senior Regulatory Affairs Associate, EU & UK Market in London employer: Hays Life Sciences
This generics pharmaceutical company is dedicated to delivering affordable medicines while fostering employee growth. Located in the UK, it offers a collaborative work culture and values high-quality research. The team is committed to navigating complex regulatory landscapes effectively.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Regulatory Affairs Associate, EU & UK Market in London
✨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 Senior Regulatory Affairs Associate, EU & UK Market 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 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.
