Regulatory affairs officer (urgent)
Qualifications:
Bachelor’s/ College Degree in Pharmacy (duly registered with the Professional Regulation Commission)
At least 3-5 years of working experience in regulatory affairs and in the pharmaceutical industry
Experience in handling Drug registration is an advantage
Must have good communication skills (both oral and written) and able to work independently or with very minimal supervision.
The Regulatory Affairs Officer shall provide technical and logistic support to legal and registration activities of the Regulatory Affairs Department to ensure compliance with the requisites of the local pharmaceutical regulatory environment.
Responsibilities:
Handle registration (review, submission and monitoring) and maintenance of all products under Drug category
Represent the company or act as liaison officer to the local FDA (for assigned products)
Assist the RA Head in complying with the local FDA’s regulatory guidelines
Provide regulatory information through preparation of registration updates, maintenance and update of product information, registration dossiers and regulatory files; submission of updated prescribing information and other updates/ variations in technical information to FDA and includes monitoring of implementation; updating of all product monographs for publication in the local compendia
Provide technical support to internal and external customers including, but not limited to:
- prompt preparation and compilation of additional regulatory requirements in support of marketing thrusts and directions
- provision of updated Certificate of Product Registration to business units for inclusion in drugstores, hospital formularies and bidding purposes
- accomplishing regulatory reports for submission to RA Head
- Assist in the management of regulatory tools and database
Act as deputy local QPPV (Qualified Person Responsible for Pharmacovigilance)
Perform other job-related duties and responsibilities as determined by RA Head and/or job-related tasks as needed by the company