At a Glance
- Tasks: Lead the EU regulatory labelling strategy for a rapidly growing biotech.
- Company: Join an innovative biotech with strong scientific momentum and a collaborative culture.
- Benefits: Competitive salary, career growth opportunities, and a dynamic work environment.
- Other info: Work in a fast-paced environment with cross-functional teams and global exposure.
- Why this job: Make a real impact in oncology while shaping labelling strategies across Europe.
- Qualifications: 10+ years in pharma/biotech with a focus on regulatory affairs and labelling.
The predicted salary is between 90000 - 110000 £ per year.
A rapidly emerging biotech with strong scientific momentum is expanding its European footprint and seeking a Director, Regulatory Affairs Labelling to lead regional labelling strategy across EU/EEA, UK and Switzerland. In this high-visibility role, you will shape and execute labelling strategy from development through post-approval, ensuring compliance with EMA and national authorities while maintaining alignment with global CCDS. You will represent European labelling on global teams and provide strategic, actionable guidance for oncology programs in a fast-scaling environment.
Key Responsibilities
- Lead EU/UK/CH labelling strategy and lifecycle execution
- Develop and maintain high-quality Product Information (SmPC/PL)
- Align regional labelling with global CCDS and target/core labelling
- Partner cross-functionally with Global RA, Clinical, Safety, Medical and Commercial
- Support regulatory submissions (MAA, variations, renewals)
- Drive labelling discussions with EMA, MHRA and Swissmedic
- Ensure rigorous quality, version control and compliant implementation of updates
What You Bring
- 10+ years in pharma/biotech, incl. 8+ years in Regulatory Affairs with labelling focus
- Strong experience with EU labelling (SmPC/PL) and EMA procedures
- Oncology experience strongly preferred
- Proven ability to lead cross-functional teams and navigate health authority interactions
- Strategic mindset, excellent communication skills, and comfort in a dynamic, fast-growing environment
Director, EU Regulatory Labelling Strategy in London employer: subrosa Health & Capital group
At subrosa Health & Capital group, we pride ourselves on fostering a collaborative and innovative work culture that empowers our employees to excel in their roles. As a Senior Medical Science Liaison, you will have the opportunity to engage with key opinion leaders and contribute to groundbreaking oncology launches, all while enjoying flexible remote work arrangements and comprehensive professional development opportunities. Join us in making a meaningful impact in the field of oncology, where your expertise will be valued and your growth supported.
Contact Details:
subrosa Health & Capital group Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Director, EU Regulatory Labelling Strategy in London
✨Get Involved in Local Research Communities
Tap into local biotechnology meetups and research forums. These are great places to mingle with industry professionals, share your passion, and even discover unadvertised job openings. It's all about getting your face known in the field!
✨Leverage University Alumni Networks
If you're a recent grad, don’t underestimate the power of your university’s alumni network! Reach out to alumni working in biotechnology to gather tips about job openings at companies like subrosa Health & Capital group. You'd be surprised how willing people are to help out a fellow grad!
✨Show Off Your Projects
Curate a portfolio showcasing any research projects or internships you've completed in biotechnology. This tangible evidence of your skills can really impress employers when you chat with them at networking events or interviews. It's about making that killer first impression!
✨Stay Up-to-Date with Industry Trends
Biotech is a fast-paced field, so keeping yourself updated with the latest advancements is crucial. Attend industry conferences, webinars, or workshops to broaden your knowledge and meet potential employers. Plus, it’ll give you fantastic talking points for your interviews at places like subrosa Health & Capital group!
We think you need these skills to ace Director, EU Regulatory Labelling Strategy in London
Some tips for your application 🫡
Show Off Your Lab Skills:In the biotechnology field, it's super important to highlight your lab experience in your CV. Be sure to mention specific techniques or instruments you've mastered (think PCR, gel electrophoresis, etc.) and any relevant projects you've worked on. This will show subrosa Health & Capital group that you have the hands-on skills they need.
Tailor Your Technical Skills:Make sure to emphasise your technical skills, especially those relevant to the biotechnology sector. Include any software tools or programming languages you've used, like R or Python for data analysis, which could be key for this role at subrosa Health & Capital group.
Craft a Compelling Cover Letter:Since this is a full-time role, your cover letter should reflect not only your passion for biotechnology but also your long-term career ambitions. Share why you're excited about the work that subrosa Health & Capital group does and how you envision contributing to their goals. This shows that you’re not just looking for any job, but you're genuinely invested in this opportunity.
Include Your Papers and Projects:If you've published any papers or contributed to significant projects, mention them! These documents can boost your application and provide tangible evidence of your expertise in the biotechnology field. Don’t forget to link to any relevant publications or project summaries—this can set you apart from other candidates.
How to prepare for a job interview at subrosa Health & Capital group
✨Brush Up on Lab Techniques
Since you're eyeing a full-time gig in biotechnology, make sure you're well-versed in the lab techniques relevant to the role. Be ready to talk about PCR, CRISPR, or any specific methods mentioned in the job description at subrosa Health & Capital group. You might even be asked to demonstrate your understanding of these processes.
✨Know Your Bioinformatics Tools
Get comfortable with bioinformatics tools that are commonly used in the industry, like BLAST or Bioconductor. These are key in biotechnology, and having hands-on experience or at least familiarity can set you apart. Prepare to discuss any relevant projects you've worked on, especially if they involved data analysis or genomic research.
✨Show Your Teamwork Skills
Biotech often involves collaboration across multiple disciplines. Be ready to share stories that highlight your teamwork and communication skills, especially in research projects. Think about working with different teams at university or any internships – this is where you can show how well you fit into subrosa Health & Capital group's culture.
✨Research Recent Biotech Innovations
Stay updated on the latest trends and breakthroughs in biotechnology. Knowing what's happening in the field can help you engage in more meaningful discussions during your interview. Bring up recent articles or advancements that excite you, especially those related to the work being done at subrosa Health & Capital group. This shows your passion for the industry!
