RA Specialist (1 Year Fixed-Term Contract)

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Vantive: A New Company Built on Our Legacy

Since last year, Baxter has been on a journey to separate our 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 sale of Vantive to funds managed by the Carlyle Group is subject to receipt of customary regulatory approvals and satisfaction of other closing conditions.

Position: RA Specialist (Contractual)

Type: Fixed-Term Contract

Duration: 12 Months

Work Location: Bangkok office (Thanapoom Building, nearby MRT Petchburi)

Report: QA/RA Manager

Work Flexibility: Intentionally Hybrid (3 Days in Office, 2 Days WFH)

Job Scope: Ensure compliance of Drugs, Medical Devices and related health products as per standards of Thai authorities as well as Baxter’s standards.

Variation of Legal Entity Name for Medical Devices & Name of Drugs
Re-Registration
GMP Clearance submission
Change Control to support local redress/ relabel
Promotional Materials for all products after variation approval

Job Descriptions:

Responsible for product registration and maintain existing registration, product registration variation including promotional material permission.
Respond to questions from regulatory authorities within strict timeline.
Support regulatory activities relating to project assignment.
Ensure regulatory compliances of Drug, Medical device and related health product operation following corporate SOP and local regulations
Co-ordinate with global/regional/related local functions on product labeling
Review promotional material or SOPs for compliance with local and global regulations
Provide RA administrative support
Data maintenance in related RA systems.
Perform other duties as assigned.

Qualifications:

Bachelor of Pharmacy or any related Science.
At least 1 year experience in Regulatory Affair (RA) in Medical Devices or Pharmacy for Healthcare Company.
Pharmacist License (will be Advantage but not mandatory).
Sound basis of Regulatory knowledge.
Language skills in Thai and English.
Strong oral and written communication and presentation skills.
Demonstrated interpersonal skills including strong negotiation skills.
Ability to independently identify compliance risks and escalate when necessary.

Benefit & Welfare:

Base Salary
Completion Bonus.
Parking contract with 3rd Party Agent.
Transportation Allowance (Reimbursement with 3rd Party Agent)
General Welfares will depend on Third party agency policy.

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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Address

Explore this location 11F Thanapoom Tower 1550 New Petchburi Road Makasan, Rajthevi
Bangkok
Bangkok 10400
Thailand Explore This Location

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RA Specialist (1 Year Fixed-Term Contract)

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