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- Tasks: Lead a regulatory team and interface with global health authorities.
- Company: Exciting pharma company based in the UK with a focus on innovation.
- Benefits: Competitive salary, career growth, and opportunities to make a real impact.
- Other info: Dynamic role with mentorship opportunities and a collaborative environment.
- Why this job: Shape the future of drug development and ensure compliance globally.
- Qualifications: Extensive regulatory affairs experience and strong leadership skills.
The predicted salary is between 80000 - 100000 £ per year.
Northreach have partnered with an exciting pharma company based in the UK that are recruiting for a Global Head of Regulatory Affairs to join their team. The role will lead the regulatory team, interfacing with regulatory agencies like the MHRA, EMA, FDA, preparing and submitting regulatory documents, and managing risk. The role requires a deep understanding of global regulations, excellent leadership skills, experience working with CMO partners and extensive knowledge of drug development.
Key Responsibilities:
- Develop and implement regulatory strategies while managing local regulatory partners and ensuring robust data management systems are in place.
- Lead the creation and execution of comprehensive regulatory plans for global markets, ensuring adherence to both local and international regulations.
- Oversee the preparation, submission, and ongoing management of regulatory documents (e.g., INDs, NDAs, MAAs) to health authorities such as the MHRA, FDA, EMA, and others.
- Provide cross-functional leadership by coordinating with internal and external teams to ensure alignment with regulatory requirements.
- Lead and develop the regulatory team, enhancing their knowledge, skills, and capabilities to effectively support the company's strategic objectives.
- Serve as the primary liaison with regulatory agencies, managing communications and facilitating timely approvals.
- Monitor global regulatory developments to ensure continuous compliance of products throughout their lifecycle.
- Identify potential regulatory risks and develop effective mitigation strategies.
- Lead training and mentorship initiatives within the regulatory affairs team, fostering regulatory expertise and growth within the organization.
Experience:
- Extensive background in regulatory affairs within the pharmaceutical, biotech, or medical device industries, with experience in global markets such as the US, EU, and Rest of World (ROW).
- Comprehensive knowledge of regulatory requirements and guidelines from agencies like the FDA, EMA, and others.
- Proven experience in leading small teams across multiple countries and time zones.
- Strong expertise in GxP (Good Practice) standards.
If you are interested in hearing more, please apply with an up to date copy of your CV and I will be in touch. All the best, Taylor
TI employer: Northreach
Contact Detail:
Northreach Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land TI
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharma industry, especially those who have experience with regulatory affairs. A friendly chat can lead to insider info about job openings or even referrals.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of global regulations and recent developments in the field. We recommend creating a cheat sheet of key points to discuss, so you can impress the hiring team with your expertise.
✨Tip Number 3
Showcase your leadership skills! Be ready to share examples of how you've successfully led teams or projects in the past. This will demonstrate your capability to manage the regulatory team effectively.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take that extra step to connect with us directly.
We think you need these skills to ace TI
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the role of Global Head of Regulatory Affairs. Highlight your experience with regulatory agencies like the MHRA, EMA, and FDA, and showcase your leadership skills in managing teams and projects.
Showcase Your Expertise: In your application, emphasise your comprehensive knowledge of global regulations and drug development. We want to see how your background aligns with the key responsibilities outlined in the job description.
Be Clear and Concise: When writing your application, keep it clear and concise. Use bullet points where necessary to make your achievements stand out, and ensure that your passion for regulatory affairs shines through.
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity. We can’t wait to hear from you!
How to prepare for a job interview at Northreach
✨Know Your Regulations
Make sure you brush up on the latest regulations from agencies like the MHRA, EMA, and FDA. Being able to discuss specific guidelines and how they impact drug development will show your deep understanding of the field.
✨Showcase Your Leadership Skills
Prepare examples that highlight your leadership experience, especially in managing teams across different countries. Think about times when you successfully led a project or mentored a colleague, as this will resonate well with the interviewers.
✨Understand the Company’s Strategy
Research the pharma company’s recent developments and regulatory strategies. Being able to align your answers with their goals will demonstrate your genuine interest and how you can contribute to their success.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle specific regulatory challenges or risks. Practise articulating your thought process and decision-making skills, as this will showcase your problem-solving abilities in real-world situations.