At a Glance
- Tasks: Lead global regulatory strategies for innovative biologics and advanced therapies.
- Company: Global biotechnology company focused on rare and serious diseases.
- Benefits: Flexible working options and opportunities for career growth.
- Other info: Collaborate with international teams and manage complex projects.
- Why this job: Make a real impact in the biotech field with cutting-edge therapies.
- Qualifications: Strong experience in Regulatory Affairs CMC, especially with FDA and EU regulations.
The predicted salary is between 60000 - 80000 £ per year.
Your new company
Our client, a global biotechnology company focused on developing innovative therapies for rare and serious diseases, is seeking an experienced Regulatory Affairs CMC Manager to join their EU Regulatory team. This is an excellent opportunity to contribute to cutting-edge biologics and advanced therapies, supporting global post-approval strategies and new market applications across both EU and US regions.
Your new role
Reporting to the Senior Director, Regulatory Affairs CMC (EU), you will play a key role in delivering global regulatory CMC strategies for commercial products. You'll collaborate with international teams across Europe and the US to ensure successful execution of regulatory submissions and lifecycle activities.
- Act as the Regulatory CMC representative at site and cross-functional meetings, providing clear regulatory guidance.
- Lead the planning, coordination, and compilation of high-quality CMC documentation for global post-approval submissions.
- Ensure all submissions comply with relevant regulatory requirements and guidelines (EU, FDA, and global standards).
- Partner with international teams to support change controls and GMP documentation.
- Contribute to global product registrations, renewals, and lifecycle management.
- Identify potential risks and proactively develop mitigation strategies.
- Support interactions with global regulatory authorities.
- Maintain strong collaboration across regulatory, technical, and operational teams.
What you'll need to succeed
- Strong experience in Regulatory Affairs CMC, ideally within biologics, biotechnology, or advanced therapies.
- Demonstrated experience with post-approval submissions and lifecycle management.
- Significant FDA experience is essential, alongside a solid understanding of EU regulations.
- Proven ability to manage complex projects and global stakeholders.
- Excellent communication and organisational skills.
What you'll get in return
Flexible working options available.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now. If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.
Senior Regulatory Affairs Manager CMC biologics in London employer: Hays Life Sciences
Join a pioneering global biotechnology company that is dedicated to developing innovative therapies for rare and serious diseases. With a strong emphasis on employee growth and collaboration, you will have the opportunity to work alongside international teams, contributing to cutting-edge biologics and advanced therapies while enjoying flexible working options that promote a healthy work-life balance.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Regulatory Affairs Manager CMC biologics 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 Hays Life Sciences. 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 Hays Life Sciences!
We think you need these skills to ace Senior Regulatory Affairs Manager CMC biologics 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 Hays Life Sciences 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 Hays Life Sciences.
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 Hays Life Sciences 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 Hays Life Sciences
✨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 Hays Life Sciences. 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 Hays Life Sciences'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 Hays Life Sciences. This shows your passion for the industry!
