Senior Regulatory Affairs Specialist

Vantive: A New Company Built On Our Legacy

 

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

 

At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

 

*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

SUMMARY

• Responsible for the implementation of regulatory strategies, obtain and maintain marketing authorizations for medicinal products and medical devices (products) and provides communication of general regulatory requirements in support of licensing of Baxter’s products at the local authorities in Israel.
• Contact point for local regulatory authorities regarding products in Israel
• Monitor applicable regulatory requirements; assure compliance with Baxter and external standards
• Establish appropriate communication within RA and with other functions
• Perform regulatory gap analysis and propose solutions
• Develop and document sound regulatory decisions and justifications
• Ensure regulatory strategies are aligned with project teams and country business objectives
• Review promotional material and SOPs for compliance with local and global regulations
• Partners with country business in country goals achievement
• Represent RA function on assigned cross-functional project teams
  
  

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Obtaining and maintenance of products licenses/authorizations for marketed products to ensure all time compliance with local legislation.
• Respond to regulatory authorities’ questions within strict deadlines.
• Perform and/or review the translation of labelling.
• Keep track of current regulatory trends in the country.
• Provide impact assessment of regulations changes: to local business, functions, and global RA.
• Document activities in Baxter data bases and systems and keep data base updated.
• Providing RA support to Baxter products distributed by Baxter or by Distributors.
• Support Israel business plan for devices by overcoming regulatory challenges, and collaboration with business leaders and supportive functions e.g supply chain, Quality etc.
• Represent Baxter Israel at local health authorities.
• Establish appropriate communication with other functions including SC, Quality etc.
• Review and approve promotional materials related to products.
• Review SOP's for compliance with local regulations & Baxter standards.
• Other activities defined by Sr RA manager to support licenses, as required by Baxter and local country legislation.
  
  

JOB REQUIREMENTS

Education
Bachelor's degree from Pharmacy school = Certified pharmacist.

Experience

2 years of experience in Registration department, responsible for all drug registration actions required by the MOH.

Appointed pharmacist is an advantage.

At least 2 years of experience with devices registration.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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