Regulatory Affairs Officer
Job Description
Description
- Ensures that the Importation/Exportation of licenses and regulatory standards are being met and followed.
- Monitors and supervises the other external consultant regulatory Pharmacists of Medtecs affiliate companies such as Medtrends Distributors Corp and U-NetDistributors Corp.
- Secures certifications from the FDA for selected medical consumable products and upcoming medical device products under Medtex Corporation.
- Secures Domestic Bidders certificate of preference.
- Secures renewal of Business Permits of Medtrends and U-Net
- Assists the consultant pharmacists of the organization in the consolidation of all documentary requirements and coordinates with HQ Taiwan/Cambodia for the necessary documents for the FDA applications of the following companies:
- Medtex Corp.
- Medtrends Distributors Corp.
- U-net Distributors Corp.
- Compile and monitor all documents properly related to FDA
- Secures authentication of the documents in the Department of Foreign Affairs (DA) and Taipei Economic Cultural Office (TECO) to be forwarded to HQ Taiwan/Cambodia.
- Submits a weekly report to his/her superior concerning the status of the Certificates/Licenses/Permits.
- Other related tasks that may be assigned by the immediate superior from time to time.
Requirement
- Must be a licensed Pharmacist with at least (1) year experience in the related field
- Must be knowledgeable in current Food and Drug Administration (FDA) procedures, regulations and affairs
- Excellent oral and written communication and interpersonal skills with experience in working with foreign manufacturing companies.
- Computer literate. Knowledgeable in Microsoft office (Word, Excel, PPT)
- Ability to establish priorities and work independently
- Hard working and flexible
- Willing to work on-site at Makati City
- Full-time position
jean dayag100% response rate
HR SupervisorMedtecs International Corp. Ltd. - Philippines
Active this month
Working Location
330 Sen. Gil Puyat Ave. Makati CityTHE, The World Centre Bldg.. H26C+HGV, Sen. Gil J. Puyat Ave, Makati, Metro Manila, Philippines
Benefits
Government Mandated Benefits
13th Month Pay, Pag-Ibig Fund, Paid Holidays, Philhealth, SSS/GSIS
Insurance Health & Wellness
HMO
Others
Company Social Events
Professional Development
Professional Development
Time Off & Leave
Maternity & Paternity Leave, Sick Leave, Vacation Leave
Posted on 15 October 2024
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