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For Companies At a Glance
- Tasks: Lead global regulatory strategy for innovative vaccines and collaborate with cross-functional teams.
- Company: A leading global biopharmaceutical organisation focused on vaccine development.
- Benefits: Competitive salary, comprehensive health benefits, and opportunities for professional growth.
- Why this job: Make a significant impact in global health by driving regulatory success for life-saving vaccines.
- Qualifications: Advanced degree and 15+ years in Regulatory Affairs, with strong leadership experience.
- Other info: Join a dynamic team dedicated to innovation and compliance in the biopharmaceutical industry.
The predicted salary is between 72000 - 108000 £ per year.
A leading global biopharmaceutical organisation with an established and growing vaccine portfolio is seeking a Head of Regulatory Affairs to lead global and regional regulatory strategy across development, licensure, and post-approval lifecycle management. This role reports into the SVP, R&D and will collaborate closely with R&D, Clinical, Quality, Manufacturing, and Commercial functions to drive product success across multiple markets.
Key Responsibilities
- Provide strategic leadership across all Regulatory Affairs functions, including CMC, Development, Post-Authorisation, EU & International Markets, North America, Partner Markets, Regulatory Operations, and Labelling.
- Develop and execute global regulatory strategies from preclinical through post-marketing stages.
- Advise senior leadership on regulatory pathways, opportunities, and risks.
- Represent the organisation in interactions with major health authorities (e.g., FDA, EMA, MHRA, WHO).
- Oversee the preparation and timely submission of high-quality regulatory filings (INDs, BLAs/MAAs, amendments, and variations).
- Monitor regulatory intelligence and assess potential business or process impacts.
- Embed regulatory considerations into development programs, including clinical plans, manufacturing, tech transfers, scale-up, and labelling.
- Build, develop, and mentor a high-performing Regulatory Affairs team, delivering across multiple priority programs in parallel.
- Lead post-approval regulatory activities and ensure ongoing global compliance.
Qualifications
- Advanced degree in a scientific, medical, or regulatory discipline (PhD, PharmD, MD, or MSc preferred).
- 15+ years' experience in Regulatory Affairs within biotech, pharma, or vaccines, including 5+ years in senior leadership.
- Experience across vaccines and/or biologics strongly preferred.
- Demonstrated success leading major regulatory submissions and approvals.
- Strong knowledge of U.S. and EU regulatory frameworks; additional global market experience is an advantage.
- Excellent leadership, communication, and stakeholder‐management capability.
- Proven ability to balance innovation, compliance, and risk in a complex, cross‐functional environment.
Head of Regulatory Affairs in London employer: Skills Alliance
Contact Detail:
Skills Alliance Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Head of Regulatory Affairs in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the biopharmaceutical industry, especially those in Regulatory Affairs. Attend industry events or webinars to meet potential employers and get your name out there.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory frameworks. Be ready to discuss your experience with major submissions and how you've navigated complex compliance issues in the past.
✨Tip Number 3
Showcase your leadership skills! Be prepared to share examples of how you've built and mentored teams in your previous roles. Highlight your ability to drive product success across multiple markets.
✨Tip Number 4
Don't forget to apply through our website! We love seeing candidates who are genuinely interested in joining our team. Tailor your approach to show how you can contribute to our regulatory strategy.
We think you need these skills to ace Head of Regulatory Affairs in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the specific skills and experiences that align with the Head of Regulatory Affairs role. Highlight your leadership experience and any relevant regulatory submissions you've led, as this will catch our eye!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how your background makes you the perfect fit for our team. Don’t forget to mention your experience with vaccines or biologics if you have it!
Showcase Your Leadership Skills: Since this is a senior role, we want to see evidence of your leadership capabilities. Share examples of how you've built and mentored teams in the past, and how you've successfully navigated complex regulatory environments.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at Skills Alliance
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulatory frameworks, especially in the U.S. and EU. Familiarise yourself with recent submissions and approvals in the biopharmaceutical sector, particularly around vaccines and biologics. This will show that you're not just knowledgeable but also passionate about the field.
✨Showcase Your Leadership Skills
As a Head of Regulatory Affairs, you'll need to demonstrate your leadership capabilities. Prepare examples of how you've built and mentored teams in the past. Think about specific challenges you faced and how you navigated them while keeping your team motivated and focused.
✨Prepare for Stakeholder Management Questions
Expect questions about how you manage relationships with various stakeholders, including senior leadership and health authorities. Have concrete examples ready that illustrate your communication skills and ability to balance innovation with compliance.
✨Think Globally
Since this role involves global regulatory strategy, be prepared to discuss your experience in different markets. Highlight any international collaborations or regulatory challenges you've tackled. This will show that you can think beyond borders and adapt strategies to diverse environments.
