At a Glance
- Tasks: Lead EU regulatory strategy and quality systems for impactful product approvals.
- Company: Dynamic biotech firm focused on expanding access to biologic therapies.
- Benefits: Competitive salary, equity options, and a hybrid work environment.
- Other info: Collaborative team culture with opportunities for leadership exposure.
- Why this job: Shape the future of biologics in Europe and drive meaningful change.
- Qualifications: Expertise in EU regulatory pathways and quality control in biologics.
The predicted salary is between 80000 - 100000 £ per year.
We are seeking an experienced and hands-on Head of Scientific Affairs, Quality & Regulatory Compliance (EU) to lead our European regulatory strategy, quality systems, and scientific oversight. This is a pivotal leadership role responsible for driving EMA interactions, establishing an inspection-ready EU GMP quality framework, and enabling successful product approvals and market entry.
This role also requires strong knowledge of and previous experience in Quality Control (QC), including analytical methods, compliance with EU GMP standards, and alignment with regulatory expectations. The ideal candidate brings deep expertise in EU regulatory pathways, biologics development (with a strong emphasis on biosimilars), and quality systems implementation.
You will combine strategic leadership with operational execution, working cross-functionally and with external partners to ensure compliance, readiness, and delivery across all stages of development and manufacturing.
Why join us?
- Build from the ground up – Play a central role in shaping our EU regulatory and quality infrastructure
- High-impact role – Direct influence on product approvals, site activation, and market entry
- Leadership exposure – Work closely with senior leadership and contribute to strategic decision-making
- Ownership & autonomy – Take full responsibility for your domain with the freedom to implement your vision
- Equity upside – Share in the company's success through a meaningful equity package
- Mission-driven – Help expand access to critical biologic therapies across Europe
- Agile environment – Join a focused, collaborative team that moves quickly and values execution
Location: UK (Hybrid)
Hours: Full-time
Contract Type: Permanent
Reporting To: General Manager, UK
Compensation: Competitive salary and meaningful equity/share option
Please send us a cover letter and your CV on careers@enabiologics.com
Head of Scientific Affairs, Quality & Regulatory Compliance (EU) in London employer: Ena Biologics
At Enabiologics, we pride ourselves on being an exceptional employer that fosters a dynamic and collaborative work culture. As the Head of Scientific Affairs, Quality & Regulatory Compliance (EU), you will have the unique opportunity to shape our regulatory and quality infrastructure while working closely with senior leadership in a mission-driven environment. With a focus on employee growth, autonomy, and a competitive compensation package that includes equity options, we are committed to expanding access to critical biologic therapies across Europe.
StudySmarter Expert Advice🤫
We think this is how you could land Head of Scientific Affairs, Quality & Regulatory Compliance (EU) in London
✨Tip Number 1
Network like a pro! Reach out to industry contacts on LinkedIn or at events. A personal connection can often get your foot in the door faster than a CV.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Show us you’re not just interested in the role, but also passionate about what we do!
✨Tip Number 3
Practice your pitch! Be ready to explain how your experience aligns with our needs in scientific affairs and regulatory compliance. Confidence is key!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. We can’t wait to hear from you!
We think you need these skills to ace Head of Scientific Affairs, Quality & Regulatory Compliance (EU) in London
Some tips for your application 🫡
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Make sure to highlight your relevant experience in regulatory compliance and quality systems. We want to see how your background aligns with our mission and the specific role.
Tailor Your CV:Don’t just send a generic CV! Tailor it to showcase your expertise in EU regulatory pathways and biologics development. We’re looking for someone who can demonstrate their hands-on experience, so make it count!
Showcase Leadership Skills:This role is all about leadership, so don’t shy away from sharing examples of how you’ve led teams or projects in the past. We want to know how you can drive our regulatory strategy and quality framework.
Apply Through Our Website:We encourage you to apply through our website for a smoother process. It helps us keep track of applications better and ensures you don’t miss out on any important updates from us!
How to prepare for a job interview at Ena Biologics
✨Know Your Regulatory Stuff
Make sure you brush up on EU regulatory pathways and GMP standards. Be ready to discuss your previous experiences with compliance and how you've navigated complex regulatory environments. This will show that you’re not just familiar with the theory but have practical insights to bring to the table.
✨Showcase Your Leadership Skills
Prepare examples of how you've led teams or projects in the past, especially in quality systems implementation or scientific oversight. Highlight your ability to work cross-functionally and how you’ve influenced strategic decisions. This role is all about leadership, so make sure you demonstrate your capability.
✨Be Ready for Scenario Questions
Expect questions that put you in hypothetical situations related to EMA interactions or product approvals. Think through potential challenges and how you would address them. This will help interviewers see your problem-solving skills and strategic thinking in action.
✨Align with Their Mission
Familiarise yourself with the company’s mission to expand access to biologic therapies. Be prepared to discuss how your values align with theirs and how you can contribute to their goals. Showing genuine interest in their mission can set you apart from other candidates.
