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Regulatory Affairs Manager

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عدد الوظائف الشاغرة

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الوصف الوظيفي

This is whereyour work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today tomorrow and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together our community is driven by a culture of courage trust and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations and we hold each other accountable for delivering exceptional results.

Here you will find more than just a jobyou will find purpose and pride.

About the Role

We are looking for a motivated and experienced Regulatory Affairs Manager to join our team in this role you will be responsible for developing and executing regulatory strategies managing new registrations and lifecycle management (LCM) and ensuring compliance with local and global regulations. You will work closely with health authorities local distributors and cross-functional teams to support Baxters product portfolio and business growth in Israel and the territory of Palestine.

This is a highly collaborative role requiring strong communication problem-solving and leadership skills as well as the ability to navigate regulatory challenges and drive business objectives forward.



Key Responsibilities


Define and implement regulatory strategies for new product registrations and lifecycle management.
Manage and maintain licenses and marketing authorizations for Baxter products in Israel.
Act as the primary liaison with the Ministry of Health (MOH) local MAHs and distributors for all regulatory matters.
Monitor regulatory requirements assess the impact of regulation or product changes and ensure compliance with Baxter standards and local legislation.
Represent Baxter Israel at local health authorities and industry groups.
Provide regulatory guidance to cross-functional teams (Supply Chain Quality Legal etc.).
Prepare and review submissions SOPs labeling and promotional materials for compliance with regulations.
Develop documentation to support regulatory decisions and justifications.
Support the Israel business plan by proactively managing regulatory risks and challenges.
Train and mentor staff; may directly supervise team members.



What We Are Looking For


University degree in Pharmacy Life Sciences or a related field.
Minimum 5 years of experience in Regulatory Affairs within the pharmaceutical biotech or medical device industry.
Strong knowledge of Israeli regulatory requirements and proven experience working with MOH.
Experience with product registration lifecycle management and regulatory submissions.
Excellent organizational communication and problem-solving skills.
Ability to work cross-functionally and influence without authority.
Fluency in Hebrew and English (spoken and written).



Why Join Us

At Baxter we are passionate about saving and sustaining lives. This role provides the opportunity to make a real impact on patients by ensuring that innovative and high-quality therapies are made available in Israel. You will be part of a collaborative and dynamic team with opportunities for professional growth and cross-regional exposure.



To apply please submit your CV in English.

Equal Employment Opportunity

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.

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.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams where fraudulent parties pose as Baxter employees recruiters or other agents and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself review our
Recruitment Fraud Notice.


Required Experience:

Manager

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