General Electric Regulatory Affairs Specialist – Switzerland (f/m/d) in Glattbrugg, Switzerland
Job Description Summary
In this key regulatory role for our Pharmaceutical Diagnostics Business in Switzerland you will deliver an effective regulatory capability in Switzerland and work on the National Regulatory Affairs (NRA) activities for Switzerland.
GE Healthcare (https://www.gehealthcare.de/) is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. 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.
Please find out more about our Pharmaceutical Diagnostics Products here (https://www.gehealthcare.de/products/nuclear-imaging-agents) !
This role can be based either in Glattbrugg near Zurich / Switzerland or in your flexible Home Office in Switzerland!
You co-operate with the RA Manager Switzerland on all RA related national topics. This includes responsibility for all local regulatory activities in support of the compliance and registration of GE Healthcare products in Switzerland. This position works closely with the RA Manager Switzerland, Global Regulatory Strategy (GRS) and local commercial groups.
You support for all marketing authorisation-relevant activities of GE Healthcare's medicinal products
You provide assistance with the submission of marketing authorisation and renewal applications, notifications of changes and PSURs to Swissmedic in co-operation with the RA Manager Switzerland
You communicate and coordinate with stakeholders to ensure the necessary measures for maintaining regulatory compliance of the existing drug approvals (Life Cycle Management)
You prepare, update and review SmPC for HCPs and PILs in the context of drug approval in compliance with the currently valid legal requirements
You are responsible for local regulatory archive
You maintain the quality management systems through the development and continuous revision of Standard operating procedures to ensure safety and the well-being of patients
You bring a Bachelor’s Degree in a relevant field such as: Regulatory Science, Biomedical Engineering, Biology, Pharmacy, Chemistry, English (with a technical writing emphasis), Legal Studies, Law, Nursing, Physician Assistance, Pharmaceutical Science
You have gained professional experience in regulatory affairs, and preferably, some experience of negotiating directly with local regulatory authorities
You have strong analytical skills
You are able to work with less supervision on projects and activities
You are able to prioritize, plan & evaluate deliverables
You have and continuously build on your knowledge & experience conducting scientific, regulatory, legal, or business research.
You bring excellent verbal and written communication and presentation skills with the ability to communicate in English and German in an "easy to understand" manner
Prior experience MS Office using Excel spreadsheet and presentation software
Desired Characteristics that can also be further developed "on the job" are:
Ability to work in a team and working independently
Decision-making competence, sense of responsibility, reliability and flexibility
Ability to work across cultures
Ability to manage regulatory processes to ensure approvals and maintenance of products
Are you interested in learning more? Then please apply online. For any question upfront please reach out to our recruiter Carolin Krone on firstname.lastname@example.org . Please note that for Data Privacy compliance we are not able to accept any e-mail applications!
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 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.
GE Healthcare – every moment matters
Relocation Assistance Provided: No