At a Glance
- Tasks: Prepare and submit regulatory documentation for clinical trials and product registrations.
- Company: Leading life sciences and medical technology organisation in London.
- Benefits: Competitive salary, health insurance, flexible working, and training reimbursement.
- Other info: Great career advancement opportunities in a growing regulatory team.
- Why this job: Join a fast-paced environment and contribute to innovative biotech and medical device products.
- Qualifications: Strong understanding of global regulatory requirements and detail-oriented skills.
The predicted salary is between 51750 - 63250 £ per year.
We are seeking a highly skilled and detail-oriented Regulatory Affairs Specialist to join a leading life sciences and medical technology organisation. In this pivotal role, you will support the development, submission, and maintenance of regulatory documentation for clinical trials, product registration, and post-market surveillance activities in accordance with FDA, EMA, MHRA, and other global regulatory bodies. This is an excellent opportunity for someone looking to contribute to regulatory strategy, gain cross-functional exposure, and work on cutting-edge biotech or medical device products within a fast-paced regulatory environment.
Job Responsibilities
- Prepare, compile, and submit regulatory documentation (INDs, CTAs, 510(k), CE marking, etc.)
- Ensure regulatory compliance with FDA, EMA, MHRA, ISO, and ICH guidelines
- Collaborate with R&D, Clinical Affairs, and Quality Assurance teams to ensure product readiness
- Maintain regulatory files, technical documentation, and product registrations across global markets
- Monitor regulatory changes and provide guidance to internal stakeholders
- Support internal and external audits and inspections
- Assist with labelling review, risk assessments, and post-market surveillance
Requirements
- Strong understanding of global regulatory requirements (FDA, EMA, MHRA, ISO 13485)
- Experience preparing and submitting dossiers and regulatory filings
- Detail-oriented with strong documentation and project tracking skills
- Proficiency with Microsoft Office and regulatory software systems
Desired Skills
- Regulatory Affairs Certification (RAC) is a plus
- Experience in regulatory submissions for medical devices, diagnostics, or biotech products
- Knowledge of eCTD publishing tools and regulatory information management systems (RIMS)
- Ability to interpret technical documentation and scientific data
Competitive salary with performance-based bonuses, private health and dental insurance, annual training and certification reimbursement, 25 days holiday + bank holidays, hybrid working model and flexible scheduling, career advancement in a growing regulatory team.
Regulatory Affairs Specialist employer: MastarRec
Join a leading biotechnology firm that prioritises innovation and compliance in the healthcare sector. With a competitive salary, hybrid working options, and a commitment to professional development, this company fosters an inclusive culture that encourages employee growth and collaboration. As a Regulatory Analyst, you'll play a vital role in shaping product development while enjoying a supportive environment that values your expertise and contributions.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Specialist
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like MastarRec. 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 MastarRec.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like MastarRec. 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 MastarRec is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Regulatory Affairs Specialist
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 MastarRec!
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 MastarRec 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 MastarRec!
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 MastarRec, 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 MastarRec
✨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 MastarRec 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 MastarRec’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.
