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Associate Regulatory Affairs

Req #: 180004TY_en
Location: Neo Irakleio, I GR
Job Category: Regulatory Affairs
Date Posted: 3/8/2018 6:19:00 AM
Baxter International


Our employees around the world are connected by an enduring commitment to save and sustain lives. This higher purpose binds us as a company in doing work that matters.
Do you want to know why it is so wonderful to work for Baxter? Go to https://www.youtube.com/watch?v=OY89yj_zSIo
The Job
The job as Regulatory Affairs Associate at Baxter is a great opportunity to develop your professional career in our Regulatory Affairs area.
Under general supervision, you will responsible for the preparation of documents/packages for regulatory submissions in Greece and Cyprus.
You will review and evaluate technical and scientific data and reports required for submission in support of Baxter’s products.
You will ensure that regulatory compliance is maintained for products.
You will act within country policies and practices to reduce Baxter´s exposure to regulatory, quality and liability risks.
You will prepare and coordinate the submissions in Cyprus and will follow-up with the representatives regarding the status of the submissions and with the MoH for the approvals.
You will compile regulatory documents for administrative variations and participate to the content preparation of regulatory documents for new products Marketing Authorizations and non-administrative/complex variations
You will review, edit and proofread regulatory documentation for drugs and devices, track of status and progress of regulatory documentation/submissions
You will initiate change request, review and approve of labeling materials, assist in preparation and review of SOP’s and other departmental documents.
You will participate as an active team member of project teams as required.
You will compile and prepare responses to regulatory authorities questions, maintain regulatory files in a format consistent with requirements, review and approve of promotional materials for compliance with local regulations.
You will maintain awareness of regulatory requirements, registration of Medical Devices in MoH’s databases in Greece and Cyprus according to country regulations.
You will support Tenders providing required regulatory documents for drugs and devices.
You will keep updated the RA Tools/SharePoints (e.g. RAS, CCDS) and department’s local Data Base.
You will be responsable for “Post Registration Actions” including approval notifications.
You will provide administrative support of the Department, logistics for meetings, trainings, travel, etc.
Do you want to learn more about our business? Go to http://www.baxter.com/inside-baxter/about/overview/corporate.page?


What we offer
It is a challenging opportunity for you and also a chance to work in a diverse team with a great mix of people. Joining Baxter means joining a team that you can truly learn from!
We encourage our employees to develop their skills to meet the demands of an ever-changing work environment, providing them with opportunities to achieve personal and professional goals that will make them valued contributors throughout their careers. If you have an interest in this great opportunity and think you can make a difference then this could well be the role for you.
If you want to learn more about career opportunities go to http://www.baxter.com/careers.page
Who we are
Baxter touches millions of lives every day. Our products and services are essential building blocks of healthcare. You’ll find Baxter’s products and therapies on nearly every floor, in almost every hospital worldwide. You’ll find us in clinics and in the home. Patients and providers rely on Baxter for lifesaving renal and medical products.
Our mission to save and sustain lives inspires our work and our commitment to expanding access to care, providing cost-effective healthcare solutions, delivering quality products and advancing innovations for the world.
Our 50,000 employees serve patients and clinicians in more than 100 countries and are dedicated to ensuring Baxter is there when patients need care.
Our inclusive culture and a diverse workforce drives innovation, creates trusted partnerships with customers, suppliers, and community partners, and contributes to the success and sustainability of our business.
Every day at Baxter is a chance to save and sustain people's lives.
Equal Opportunity Employer Discrimination: Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.



Who you are
  • College/University diploma/degree or country equivalent in health sciences or related scientific discipline with minimum 2 years' of regulatory experience, preferably within a healthcare environment
  • Ability to apply scientific/clinical knowledge
  • Written and verbal communication skills
  • Fluent in English, listening and reading comprehension, speaking and writing
  • Knowledge of regulations
  • Technical systems skills (e.g. word processing, spreadsheets, databases, online research)
  • Proofreading and editing skills
  • Ability to contribute to multiple projects from a regulatory affairs perspective
  • Ability to multi-task and prioritize
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