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For Companies At a Glance
- Tasks: Lead regulatory strategies and manage submissions to health authorities globally.
- Company: Exciting pharma company based in the UK with a focus on innovation.
- Benefits: Competitive salary, career growth opportunities, and a dynamic work environment.
- Why this job: Make a real impact in global drug development and regulatory affairs.
- Qualifications: Extensive regulatory affairs experience in pharma or biotech, with leadership skills.
- Other info: Join a collaborative team and enhance your expertise in a fast-paced industry.
The predicted salary is between 72000 - 108000 £ per year.
About the job
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.
TI - Global Regulatory Affairs Director in England employer: Northreach
Contact Detail:
Northreach Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land TI - Global Regulatory Affairs Director in England
✨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 a referral.
✨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 responses to show off your expertise.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, drop a quick thank-you email to express your appreciation and reiterate your interest in the role. It keeps you fresh in their minds!
✨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 England
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 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 possible 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 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. Think about challenges you've faced and how you motivated your team to achieve regulatory goals.
✨Understand the Company’s Strategy
Research the company’s current projects and regulatory strategies. Be ready to discuss how your experience aligns with their objectives and how you can contribute to their success in global markets.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving skills, particularly around risk management and compliance. Prepare scenarios where you identified regulatory risks and implemented effective mitigation strategies.
