Baxter Hiring Regulatory Affairs Officer Apply Now share with Job seekers
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
TO APPLY CLICK HERE
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