This is an entry level role for those who are looking to start a career in Regulatory Affairs. As a Global Regulatory Affairs specialist you will be supporting Marketing Authorization activities with varying levels of responsibility, autonomy and roles assigned. This role supports key specific parts of the lifecycle management process of Marketing Authorization maintenance, for example, CPP management, legalization of documentation, labelling aspects and obtaining necessary Regulatory fees. You will be responsible for providing support to regulatory submissions in an efficient and timely manner through cross collaboration with multiple stakeholders and uphold “right first time” submission quality and timeliness.
Ensure Global Regulatory Affairs staff are supported with their submissions by providing the relevant support on document requests with minimal direction.
Lead and develop process improvement within the tasks assigned.
Plan, prepare and implement simple submissions (if possible), and assist with the preparation and planning of regulatory submissions.
Build strong internal and external networks with key stakeholders to share Regulatory knowledge and understanding of requirements and further cross functional support.
Act as a central contact and owner for the Regulatory activities assigned.
Liaise with Regional Regulatory Heads and National Regulatory Affairs on regulatory aspects that will impact their territories.
Ensure key actions within the Regulatory systems are performed within appropriate timeframes and to the accepted quality.
Support forums for sharing of best practices and lessons learned related to regional regulatory activities, ensuring a globally coordinated approach and no duplication of effort across territories relating to role aspects.
Broaden knowledge on the fundamentals of Regulatory Affairs by understanding key regulations and guidance relevant to product area and dosage forms.
Understand and learn the key business drivers of GE Healthcare Pharmaceutical Diagnostics.
Fundamental experience in Regulatory Affairs with a minimum 2 years Regulatory Affairs experience or education
Must demonstrate good attention to detail
Flexible approach to task and workload management
Enthusiasm and drive for personal development
Ability to organise, prioritise and manage multiple projects
Autonomous and self-motivated
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, g ender identity or expression, 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.
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.
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Relocation Assistance Provided: No
