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- Tasks: Lead a global regulatory team and interface with major health authorities.
- Company: Exciting UK-based pharma company with a focus on innovation.
- Benefits: Competitive salary, leadership opportunities, and a chance to shape global regulations.
- Why this job: Make a real impact in the pharmaceutical industry while leading a dynamic team.
- Qualifications: Extensive regulatory affairs experience and strong leadership skills required.
- Other info: Opportunity for career growth in a fast-paced, global environment.
The predicted salary is between 72000 - 108000 £ 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.
- 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.
TI - Global Regulatory Affairs Director in London employer: Northreach
Contact Detail:
Northreach Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land TI - Global Regulatory Affairs Director in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharma industry, especially those who have experience in 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 list of potential questions and practicing your answers to showcase your expertise.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, send a thank-you email to express your appreciation and reiterate your interest in the role. It keeps you fresh in their minds and shows your enthusiasm.
✨Tip Number 4
Apply through our website for the best chance at landing that dream job! We make it easy for you to showcase your skills and experience directly to hiring managers.
We think you need these skills to ace TI - Global Regulatory Affairs Director in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the role of Global Regulatory Affairs Director. 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 GxP standards. We want to see how your background aligns with the requirements of the role, so don’t hold back on sharing relevant experiences!
Be Clear and Concise: When writing your application, keep it clear and concise. Use bullet points where possible to make it easy for us to read through your qualifications and achievements. We appreciate straightforward communication!
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 the role. Plus, it shows you’re keen on joining our team at StudySmarter!
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 depth of knowledge and commitment to the role.
✨Showcase Your Leadership Skills
Prepare examples that highlight your leadership experience, especially in managing teams across different countries. Discuss how you've successfully led regulatory strategies and mentored team members to enhance their skills.
✨Be Ready for Scenario Questions
Expect questions about potential regulatory risks and how you would mitigate them. Think through some real-life scenarios where you had to navigate complex regulatory challenges and be ready to share your thought process.
✨Communicate Clearly
As the primary liaison with regulatory agencies, clear communication is key. Practice articulating your thoughts concisely and confidently, especially when discussing technical regulatory documents and strategies.
