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- Tasks: Lead the regulatory team and interface with global regulatory agencies.
- Company: Join an exciting pharma company based in the UK making a global impact.
- Benefits: Opportunity for leadership, mentorship, and working with international teams.
- Why this job: Shape global regulatory strategies and ensure compliance while developing your skills.
- Qualifications: Extensive experience in regulatory affairs and knowledge of global regulations required.
- Other info: Be part of a dynamic team focused on drug development and innovation.
The predicted salary is between 72000 - 108000 £ per year.
About the job TI – Global Regulatory Affairs Director
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
#J-18808-Ljbffr
TI - Global Regulatory Affairs Director employer: Northreach
Contact Detail:
Northreach Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land TI - Global Regulatory Affairs Director
✨Tip Number 1
Make sure to highlight your experience with regulatory agencies like the MHRA, EMA, and FDA in your conversations. This will show that you have the necessary knowledge and connections to navigate the regulatory landscape effectively.
✨Tip Number 2
Demonstrate your leadership skills by discussing specific examples of how you've successfully led teams in a global context. This is crucial for a role that requires managing a diverse regulatory team across multiple countries.
✨Tip Number 3
Stay updated on the latest global regulatory developments and be prepared to discuss how these changes could impact the company’s products. This shows your proactive approach and commitment to compliance.
✨Tip Number 4
Prepare to talk about your experience in developing regulatory strategies and risk management. Being able to articulate your thought process in these areas will demonstrate your strategic thinking capabilities.
We think you need these skills to ace TI - Global Regulatory Affairs Director
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Global Regulatory Affairs Director position. Tailor your application to highlight your relevant experience in regulatory affairs, especially in the pharmaceutical industry.
Highlight Leadership Experience: Since the role requires excellent leadership skills, emphasize your experience in leading teams, particularly in a regulatory context. Provide specific examples of how you've successfully managed teams and projects in the past.
Showcase Regulatory Knowledge: Demonstrate your comprehensive knowledge of global regulations and guidelines from agencies like the FDA and EMA. Include specific instances where you've navigated complex regulatory environments or submitted key regulatory documents.
Tailor Your CV: Ensure your CV is up to date and tailored to the job description. Focus on your experience with drug development, risk management, and any relevant training or mentorship initiatives you've led within regulatory affairs.
How to prepare for a job interview at Northreach
✨Showcase Your Regulatory Expertise
Be prepared to discuss your extensive background in regulatory affairs, particularly within the pharmaceutical and biotech industries. Highlight specific experiences with global regulations and how you've successfully navigated complex regulatory environments.
✨Demonstrate Leadership Skills
Since the role involves leading a regulatory team, be ready to share examples of how you've effectively managed teams across different countries and time zones. Discuss your approach to mentoring and developing team members' skills.
✨Understand the Company’s Regulatory Landscape
Research the company’s products and their current regulatory status. Familiarize yourself with recent developments in global regulations that may impact their operations, and be prepared to discuss how you would address these challenges.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities in real-world regulatory scenarios. Think about potential regulatory risks you’ve encountered in the past and how you developed effective mitigation strategies.
