At a Glance
- Tasks: Coordinate regulatory submissions and ensure compliance with packaging and labelling requirements.
- Company: Leading supplier of specials and clinical trial medicines in the UK.
- Benefits: Competitive salary up to £50,000, private healthcare, pension, and bonuses.
- Other info: Hybrid role with excellent career advancement opportunities.
- Why this job: Make a real impact in a collaborative QA & Regulatory team.
- Qualifications: 2 years experience in Regulatory Affairs within the pharmaceutical industry.
The predicted salary is between 45000 - 50000 £ per year.
Evolve are partnering with a leading supplier of specials and clinical trial medicines in the UK to recruit a Regulatory Affairs Officer. This is a fantastic opportunity to join a collaborative QA & Regulatory team, supporting regulatory submissions, product lifecycle management, packaging and labelling compliance, and interactions with the MHRA. If you’re looking for a varied role where you can make a real impact, we’d love to hear from you. This is a full time 12-month fixed term hybrid contract position working 2 days per week at our client’s head office in Leicester.
Why Apply?
- Excellent Salary & Benefits - A competitive starting salary of up to £50,000 DOE, plus exceptional bonus, private healthcare, pension, and much more!
- Collaborative Culture - Thrive in a supportive, people-focused environment.
- Career Advancement - Diverse development paths in an inclusive workplace that nurtures growth and progression.
Ideal Requirements for the Regulatory Affairs Officer
- At least 2 years proven experience in Regulatory Affairs within the pharmaceutical industry, with a strong track record of managing packaging and labelling updates and building effective relationships with regulatory authorities, including competent authorities.
- Strong knowledge of medicinal product packaging and labelling requirements, with a sound understanding of relevant regulatory guidance, including Title V of Council Directive 2001/83/EC.
- Hands‑on experience with eCTD submissions and regulatory documentation, including marketing authorisation applications (MAAs), IMPDs and/or IND/NDA submissions.
- A solid understanding of quality systems, with experience implementing new processes and driving continuous improvements to enhance regulatory compliance and operational efficiency.
Role Responsibilities for the Regulatory Affairs Officer
- Lead the end-to-end coordination of regulatory submissions, including preparing, submitting and maintaining eCTD sequences, while supporting variations and managing communications with regulatory authorities such as the MHRA.
- Drive regulatory strategy for innovative and established products, partnering with cross-functional teams to shape development plans and support key regulatory milestones, including marketing authorisations and scientific advice.
- Own product lifecycle regulatory compliance, coordinating updates to SmPCs, labels and packaging, ensuring robust change control processes are implemented and regulatory dossiers remain current.
- Collaborate with internal and external stakeholders to deliver successful regulatory outcomes, working closely with quality, operations, purchasing and clients while providing regulatory review and approval of marketing materials.
Equal Opportunities
Equal opportunities are important to us. We believe that diversity and inclusion are critical to our success as a company. We encourage applications from everyone, regardless of background, gender identity, sexual orientation, disability status, ethnicity, belief, age, family or parental status, and any other characteristic.
Regulatory Affairs Officer in Leicester employer: Evolve
Evolve is an exceptional employer, offering a supportive and collaborative work culture that prioritises patient safety and employee development. As a Pharmacy Accuracy Lead & Process Coach, you will benefit from competitive salaries, comprehensive training opportunities, and a commitment to continuous improvement in a leading UK pharmaceutical company, making it an ideal place for those seeking meaningful and rewarding employment.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Officer in Leicester
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Evolve. 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 Evolve.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Evolve. 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 Evolve is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Regulatory Affairs Officer in Leicester
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 Evolve!
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 Evolve 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 Evolve!
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 Evolve, 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 Evolve
✨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 Evolve 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 Evolve’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.
