Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries.
Post : Regulatory Affairs Officer
• To preferably know how to deal with FDA and IPO, PDEA and DENR regulations
• To be responsible for evaluation and submission of New product Dossier to FDA.
• To prepare and file documents for initial application, variations and renewals
• To evaluate and assess completeness & quality of initial registration documents and requirements as per ACTD guidelines
• To check artworks for new products and also for commercial products before shipments
• To be responsible for checking NOD (Notice of Deficiency) from FDA and providing response to FDA in a timely manner
• To be responsible to liaise and submit necessary applications, and to follow up for all applications from FDA ,PDEA and DENR to get approvals within timeline
• To handle FDA related matters such as proper compliance with standard regulations on licenses, technical documents, and product registrations, and to be able to submit compliance on or before the deadline FDA
• To ensure that the company's products comply with the regulations of the FDA & PDEA
• To prepare semi- annual report, 1st & 2nd notices and local & import permit applications for PDEA submission for Securing Import permit and local permit in timely manner
• To be responsible for preparing CPR renewal and variation application
• To be responsible for evaluation of documents based on GMP clearance list and submission to FDA.
• To be responsible for timely renewals of PDEA (Philippine Drug Enforcement Agency) License and License to Operate Renewal (LTO)
• To be responsible for handling and monitoring product complaint such as ADR and any product recall.
• To be responsible for Reviewing and checking Pharmacovigilance agreement
• Pollution Control Officer for destruction of any unused / Expired pharmaceutical product/samples.
• To be able to communicate with the Indian counterparts and guide them accordingly on the regulatory requirements of FDA and IPO
Location : Ahmedabad, Gujarat, India
Industry Type : Pharma/ Healthcare / Clinical research
Functional Area : Regulatory Affairs
End Date : 30th September, 2020
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