At a Glance
- Tasks: Lead global regulatory strategy and submissions across diverse international markets.
- Company: Dynamic biopharmaceutical company offering a high-impact environment.
- Benefits: Competitive salary, hybrid work model, and opportunities for career growth.
- Other info: Join a fast-paced team where your contributions are valued.
- Why this job: Make a real impact in a growing company and gain broader exposure.
- Qualifications: 5+ years in EU Regulatory Affairs with strong submission experience.
The predicted salary is between 50000 - 60000 £ per year.
Cpl Life Sciences is partnering with a growing biopharmaceutical business to hire a Regulatory Affairs Manager into their global team. This is an excellent opportunity for someone looking to step away from large pharma into a more agile, high-impact environment, where you’ll gain broader exposure, real ownership, and visibility across the business.
Why make the move?
- Take ownership of global regulatory strategy and submissions
- Work across international markets (EU, Middle East, Asia, Australia)
- Gain exposure beyond siloed big pharma roles
- Be part of a growing, dynamic company where your impact is visible
Job Responsibilities:
- Leading end-to-end regulatory activities across the product lifecycle
- Managing international submissions (MAAs, variations, CTAs, lifecycle)
- Acting as the regulatory lead across cross-functional teams
- Engaging directly with health authorities and global partners
- Contributing to CTD authoring and regulatory strategy
Requirement:
- 5+ years in EU Regulatory Affairs (medicinal products)
- Strong MRP/DCP experience (essential)
- Proven submission and strategy delivery experience
- Confident working cross-functionally and with regulators
- A proactive mindset suited to a fast-paced, growing business
An excellent opportunity for the right person to take the next step within their regulatory career and gain exposure within an exciting environment. This is a hybrid role, requiring 3x a week on site in Hampshire, UK. Please also note this role does not offer job sponsorship. You MUST hold the full right to work in the UK with no restrictions.
Regulatory Affairs Manager in Southampton employer: Cpl Life Sciences
Cpl Life Sciences offers an exceptional work environment for a Regulatory Affairs Manager, providing the chance to thrive in a dynamic biopharmaceutical setting. With a focus on employee growth and a culture that values ownership and visibility, you will engage in meaningful projects across international markets while enjoying the flexibility of a hybrid work model in North Hampshire. Join us to make a tangible impact in a company that prioritises innovation and collaboration.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Manager in Southampton
✨Unlock Networking Opportunities
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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 Cpl Life Sciences.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Cpl 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 Cpl 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 in Southampton
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 Cpl 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 Cpl 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 Cpl 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 Cpl 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 Cpl 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 Cpl 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 Cpl 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.
