At a Glance
- Tasks: Lead regulatory strategy for medicinal products and ensure compliance for product launches.
- Company: Join a leading pharmaceutical organisation focused on Dermatology.
- Benefits: Hybrid work, competitive salary, and a supportive team environment.
- Other info: Collaborative culture with opportunities for professional growth and development.
- Why this job: Make a real impact in the healthcare sector while developing your regulatory expertise.
- Qualifications: 5+ years of UK & Ireland regulatory experience and a degree in Life Sciences.
The predicted salary is between 50000 - 65000 £ per year.
Our client, a leading pharmaceutical organisation specialising in Dermatology, is seeking an experienced Senior Regulatory Affairs Specialist to support UK & Ireland regulatory activities across medicinal products, medical devices and cosmetics. This role provides strategic and hands-on regulatory leadership, ensuring compliance and enabling product launches and lifecycle management.
Key Responsibilities
- Lead UK & Ireland regulatory strategy across POM (including biologics), P and GSL medicines.
- Manage submissions including MAH transfers, variations, renewals, PSURs/PBRERs.
- Partner with Global Regulatory Affairs to deliver accelerated approval strategies.
- Support product launches and ongoing product availability.
- Review and approve promotional and non-promotional materials for regulatory compliance.
- Maintain packaging artwork updates via Veeva PromoMats.
- Build strong relationships with MHRA and HPRA.
- Monitor regulatory and industry developments and assess business impact.
- Support GxP inspections and ensure all products meet regulatory requirements.
- Maintain regulatory files, documentation and databases.
- Provide guidance, training and ad-hoc regulatory support to internal teams.
Experience & Skills
- Degree in Life Sciences.
- Minimum 5 years' UK & Ireland regulatory experience (pre- & post-approval).
- Strong experience interacting with MHRA and HPRA.
- Deep understanding of post-Brexit/Windsor Framework regulatory pathways, including the International Recognition Procedure.
- Excellent attention to detail, documentation quality and cross-functional collaboration.
- Strong communication, project management and stakeholder engagement skills.
- Fluent in English (written and spoken).
Behavioural Competencies
- Consumer and patient-focused.
- Collaborative and open communicator.
- Innovative and proactive.
- Delivers high-quality, right-first-time outcomes.
Monday to Friday, 37.5 hours per week. 12 month Temporary contract. 3 days per week, hybrid based in Euston, London.
Senior Regulatory Affairs Specialist UK and Ireland employer: Gi Group
Gi Group is an excellent employer for those passionate about renewable energy, offering a supportive work culture that prioritises mentorship and collaboration. With flexible working hours, generous holiday allowances, and a commitment to employee growth, you'll find meaningful opportunities to contribute to the UK's clean energy transition while developing your skills in a dynamic environment.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Regulatory Affairs Specialist UK and Ireland
✨Get Familiar with Temporary Roles in Pharma
Temporary positions in the pharmaceutical industry often arise during specific periods, like product launches or seasonal hiring sprints. Keep an eye on timelines and be proactive in reaching out to companies, especially around these busy times!
✨Join Pharma Networking Events
Participate in local and virtual pharmaceutical networking events or job fairs. This is a fantastic way to get in front of hiring managers and learn more about temporary opportunities directly from those in the know.
✨Leverage Your University Career Services
If you’re a student or recent grad, tap into your university’s career services which often have specific connections to pharma companies looking to fill temporary roles. They might even have exclusive internship programmes that lead to temp jobs!
✨Be Visible Online and Offline
Utilise platforms like LinkedIn to share your interests in temporary roles and connect with industry professionals. Plus, consider writing about relevant pharmaceutical topics to showcase your knowledge and enthusiasm—this can help you stand out to hiring companies like Gi Group.
We think you need these skills to ace Senior Regulatory Affairs Specialist UK and Ireland
Some tips for your application 🫡
Highlight Your Relevant Experience:In the pharmaceutical industry, it's crucial to showcase any relevant experience you have, whether it's internships, lab work, or coursework. Let’s emphasise your familiarity with drug development processes and any hands-on experience you've had with lab equipment or clinical trials in your CV.
Mention Certifications and Training:If you’ve got any certifications relevant to pharmaceuticals, like Good Clinical Practice (GCP) or a certification in pharmacovigilance, make sure to include them. These show your commitment to the field and can make a positive impact on your application for a temporary role at Gi Group.
Show Your Flexibility and Availability:Temporary positions often require immediate availability and flexibility in working hours. In your cover letter, make it clear when you can start and your ability to adapt to changing schedules, as this is key to a successful application.
Express Your Learning Goals:Since this is a temporary role, we suggest discussing what you hope to learn or gain from the experience at Gi Group. This not only shows your eagerness but also helps employers see you as someone who’s ready to make the most out of the opportunity.
How to prepare for a job interview at Gi Group
✨Know Your Regulations
In the pharmaceutical industry, it’s crucial to understand key regulations like GMP (Good Manufacturing Practices) or GCP (Good Clinical Practices). Brush up on these standards and be ready to discuss how they influence your work approach during your interview with Gi Group.
✨Emphasise Adaptability
Since this is a temporary role, show that you're ready to hit the ground running. Share examples from your past experiences that demonstrate your ability to adapt quickly to new environments or changes, especially in a fast-paced setting like pharmaceuticals.
✨Highlight Relevant Skills and Tools
Whether it’s laboratory techniques or software like LabWare or SAS, make sure you can confidently talk about your technical skills. If you have experience with any specific tools used in previous roles, relate that directly to how it can help Gi Group achieve its goals.
✨Prepare for Technical Questions
Be ready for technical questions related to drug development processes or quality assurance. We should expect scenarios where you might have to troubleshoot a problem or suggest improvements on a project—this shows your problem-solving capability in a temporary role.
