RA Specialist (1 Year Contract)

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.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 is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.Position: RA Specialist (1 Year Contract)Type: Fixed-Term ContractDuration: 12 MonthsWork Location: Bangkok office (Thanapoom Building, nearby MRT Petchburi)Report: QA/RA ManagerWork 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 Vantive’s standards.Variation of Legal Entity Name for Medical Devices & Name of DrugsRe-RegistrationGMP Clearance submissionChange Control to support local redress/ relabelPromotional Materials for all products after variation approvalJob DescriptionsResponsible 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 regulationsCo-ordinate with global/regional/related local functions on product labelingReview promotional material or SOPs for compliance with local and global regulationsProvide RA administrative supportData maintenance in related RA systems.Perform other duties as assigned.QualificationsBachelor 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 & WelfareBase SalaryCompletion Bonus.Parking contract with 3rd Party Agent.Transportation Allowance (Reimbursement with 3rd Party Agent)General Welfares will depend on Third party agency policy.Reasonable AccommodationVantive 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. Form LinkRecruitment Fraud NoticeVantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive 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.