POSITION OBJECTIVE:The pharmacist assistant regulatory primary job is to assist and helps the regulatory pharmacist in all regulatory matters and concerns related to FDA, IPO, and other areas where pharmaceutical expertise is relevant.
To ensure the appropriate licensing, marketing, and legal compliance of pharmaceutical and medical products in order to control the safety and efficacy of products in local government agencies as specified below.
May be required to do another task that may be assigned from time to time.
- ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
FOOD AND DRUG ADMINISTRATION
- Ensuring that a company's products comply with the regulations of the FDA standards;
Preparing submissions of dossiers to strict deadlines like Renewal Registration, Amendment / Variations, re-issuance of CPR, Query Letters, and other concerns relative to FDA approval.
- Monitoring and setting timelines for license or product variations, renewal, or any kind of registration that has been submitted to the FDA;
Batch Notification submission of some antibiotics for JF and distributor's product.- Updates and advise the office of new mandatory rules and regulations released by the FDA.
Attend Seminars and Public Consultations in FDA relevant to the company's concern.
- Advise suppliers and manufacturers on FDA regulatory requirements;
Negotiating with regulatory authorities for the submission of dossiers or other concerns.- Ensure proper storage, labeling, and packaging requirements of the products.
Assist by preparing, and submitting CLIDP applications and other regulatory matters
- Intellectual Property Office Phil (IPOPHL)
Submit Trade mark applications of all JF Draf Brand Names.- Monitors all trademarks application and certifications of brand names.
Filing of Declaration of Actual use within 3 years.
- Filing of Declaration of Actual use within one year from the 5th Anniversary of the date of registration or renewal.
UST-CEDRES
- Submit local assay of CNS and Non-CNS products.
Monitor the submitted products.- Safe keeping of all Certificates of Analysis from the local assay.
Ensure the appropriate licensing, marketing, and legal compliance of pharmaceutical and medical products in order to control the safety and efficacy of products in local government agencies as specified below.
- Communicates and negotiates with all foreign Manufacturers regarding our regulatory concerns and request.
Approval of packaging artworks from the supplier's print proofs and certificate of analysis.- Assisting with registrations, and queries of other products of Buenatech Inc., HI- Six Marketing at FDA or IPO.
Assisting in marketing compliance of promotional materials.
- Reports any incident pertaining to product complaints and advises necessary remedial action.
Facilitate all concerns and requests of our local distributors like Allbiopharma, Marzan, Pharmasilv, AMK, and others specifically regulatory matters.- Communicates and negotiates with all foreign Manufacturers regarding our regulatory concerns and request.
Approval of packaging artworks from the supplier's print proofs and certificate of analysis.
- Safekeeping and monitoring the validity of all original documents, certificates from the FDA, and others.
Ensure and supervise the storage condition and quality of drug products.- Monitors other product existing in the market, and conduct price canvass for new product development.
Submit CLIDP and mother products inventory for non-CNS drugs of distributors quarterly for monitoring and reference
- Register all drug products to GS1 Philippines regarding Barcode or GTIN
Compliance with procedures, guidelines, and policies and performing other tasks that may be assigned from time to time
Job Type: Full-time
Schedule: Day shift
Education:
Experience:
- Pharmacist Assistant Regulatory: 1 year (Preferred)
License/Certification:
* Pharmacist License (Preferred)
