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- Tasks: Lead global regulatory strategies for innovative pharmaceutical diagnostics in a remote role.
- Company: Join GE HealthCare, a leader in medical technology and digital solutions, dedicated to limitless healthcare.
- Benefits: Enjoy flexible working options, competitive salary, and a supportive culture that fosters growth.
- Why this job: Make a real impact on global health while collaborating with diverse teams in a dynamic environment.
- Qualifications: Experience in regulatory submissions and strong communication skills are essential for success.
- Other info: This is a full-time position with no relocation assistance provided.
The predicted salary is between 43200 - 72000 £ per year.
Global Regulatory Lead Pharmaceutical Development
4 days ago Be among the first 25 applicants
Direct message the job poster from GE HealthCare
Talent Acquisition | Recruitment | Executive Search
Job Description Summary
As a Global Regulatory Lead, you will contribute to the development, from pre-clinical through clinical studies to initial registration in key global markets, of pharmaceutical diagnostics. This includes ‘tracers’ targeting biomarkers of neurodegenerative diseases, cardiac function and oncology tumor expression. You will be ‘the face’ of the Global Regulatory function on cross-functional global project teams for new product introductions and single point of accountability for Global Regulatory Strategy Leadership and policy development. You will work remotely, based in Europe.
Job Description
GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
Pharmaceutical Diagnostics (PDx) business is the number one global supplier of contrast media and molecular imaging agents used to enhance medical imaging exams. Used throughout all major disease area diagnostic and treatment pathways, PDx products support three patients every second around the world.
Essential Responsibilities
- Lead assigned global program development regulatory strategy and co-ordinate with National Regulatory Affairs (NRA) regulatory submission readiness.
- Working with NRA, ensure timely GRA input to global development programs.
- For assigned programs/projects, identify regulatory opportunities, potential risks, and mitigations.
- Guide, influence and motivate, internal and external stakeholders to meet GE HealthCare business and development project team objectives.
- Fulfillment of RA compliance obligations.
Basic Requirements
- Proven track record of leading successful Pan European (CP, DCP, MRP), European national and US NDA/BLA licensing submissions
- Proven track record of leading successful interaction with HA and relevant stakeholders.
- Proven expertise with clinical related regulations/guidance as it relates to development of product submissions.
- Knowledge of preclinical and CMC as it relates to development of product submissions
- Knowledge of regulatory frameworks and external environments as it applies to project specific global regulatory strategy document (GRSD) delivery.
- Ability to drive new regulatory approaches to improve and expedite development products submissions to meet business/project objectives and patient needs.
- Ability to clearly convey and exchange information with internal and external stakeholders.
Behaviors
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
Total Rewards
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support
Inclusion & Diversity
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or age, disability, protected veteran status or other characteristics protected by law. We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
Additional Information
Relocation Assistance Provided: No
Seniority level
-
Seniority level
Director
Employment type
-
Employment type
Full-time
Job function
-
Job function
Legal
-
Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing
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Global Regulatory Lead Pharmaceutical Development employer: GE Healthcare
Contact Detail:
GE Healthcare Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Global Regulatory Lead Pharmaceutical Development
✨Tip Number 1
Familiarise yourself with the latest regulatory guidelines and frameworks relevant to pharmaceutical diagnostics. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in a rapidly evolving field.
✨Tip Number 2
Network with professionals in the regulatory affairs sector, especially those who have experience with GE HealthCare or similar companies. Engaging in conversations can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully led regulatory submissions in the past. Highlighting your achievements in navigating complex regulatory environments will set you apart from other candidates.
✨Tip Number 4
Showcase your ability to work collaboratively with cross-functional teams. Be ready to share experiences where you've influenced stakeholders and driven project objectives, as this is crucial for the role at GE HealthCare.
We think you need these skills to ace Global Regulatory Lead Pharmaceutical Development
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a Global Regulatory Lead. Familiarise yourself with the key aspects of regulatory strategy and compliance in pharmaceutical development.
Tailor Your CV: Highlight your relevant experience in regulatory affairs, especially any successful submissions you've led. Use specific examples that demonstrate your expertise in European and US licensing processes.
Craft a Compelling Cover Letter: In your cover letter, express your passion for healthcare innovation and how your background aligns with GE HealthCare's mission. Mention your ability to lead cross-functional teams and your experience with regulatory frameworks.
Showcase Your Soft Skills: Emphasise your communication and leadership skills in both your CV and cover letter. Provide examples of how you've influenced stakeholders and driven projects to success, as these are crucial for the role.
How to prepare for a job interview at GE Healthcare
✨Understand Regulatory Frameworks
Familiarise yourself with the specific regulatory frameworks relevant to pharmaceutical diagnostics. Be prepared to discuss how these regulations impact product submissions and your approach to navigating them.
✨Showcase Your Leadership Skills
As a Global Regulatory Lead, you'll need to guide and influence stakeholders. Prepare examples of how you've successfully led teams or projects in the past, particularly in a regulatory context.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities in real-world scenarios. Think about potential regulatory challenges you might face in this role and how you would address them.
✨Communicate Clearly and Confidently
Effective communication is key in this role. Practice articulating complex regulatory concepts in a clear and concise manner, as you'll need to convey information to both technical and non-technical stakeholders.
