Global Regulatory Lead Pharmaceutical Development
Global Regulatory Lead Pharmaceutical Development
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Job Description
Job Title: Global Regulatory Lead Pharmaceutical Development
Job Location: Chalfont St Giles Chalfont Saint Giles HP8 UK
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: Director
As a Global Regulatory Lead you will contribute to the development from preclinical 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 crossfunctional 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 worldchanging 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 coordinate 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.
- 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.
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 worldchanging 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
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Employment Type
Full Time
