Duties and Responsibilities:
Initial, renewal, maintenance of all e-portal accounts of AMB HK Enterprises Inc., PhilRx Pharma Inc. and FSPC Pharmaceuticals Inc.
Initial, renewal, variations and maintenance of all LTO (License to Operate) of AMB HK Enterprises Inc., PhilRx Pharma Inc. and FSPC Pharmaceuticals Inc.
Attend and facilitate FDA local inspections for AMB HK Enterprises Inc., and PhilRx Pharma Inc. Provide solutions and submit compliances based from the inspection report given by the FDA.
Attend and facilitate FDA foreign GMP inspections for AMB HK Enterprises Inc. Provide solutions and submit compliances based from the inspection report given by the FDA.
Initial, renewal, variations and maintenance of all GMP and permit to register of AMB HK Enterprises Inc., PhilRx Pharma Inc. and FSPC Pharmaceuticals Inc.
Inquire for quotation, prepare product and documents to conduct potency assay, bioavailability and clinical trials from CEDRES / UP IPS.
Application for importation certificates for regulated drugs in PDEA (Philippine Drug Enforcement Agency).
Application for importation certificates for food supplements in SRA (Sugar Regulatory Authority).
Initial CPN (Certificate of Product Notification) application for Cosmetics.
Foreign agreements with drug manufacturers under AMB HK Enterprises Inc., PhilRx Pharma Inc. and FSPC Pharmaceuticals Inc.
Local distributorship agreements for clients with other members of the team.
Sales promotion applications of AMB HK Enterprises Inc., PhilRx Pharma Inc. and FSPC Pharmaceuticals Inc.
IPO registration, publication, declaration of actual use, varaitions, renewal and maintenance under AMB HK Enterprises Inc., PhilRx Pharma Inc. and FSPC Pharmaceuticals Inc.
Initial, renewal, variations and maintenance of CLIDP (Baby CPR) applications.
Renewal applications and validity extensions of Drug PCPR (Mother CPR) .
Application for brand name clearances.
Draft labels for artworks together.
Major, minor and notification variation applications.
Provide necessary support such as regulatory information and answer queries of other departments for the benefit of AMB group of companies.
Field work as official business for the purpose of application submissions and FDA related transactions in FDAC Alabang, CEDRES, UP, PDEA, and SRA.
Notarize IAFs, draft letters, emails, request payments, brand name clearances of the applications.
Attend clients' requests in mail
Solving major to minor concerns and problems of clients and other departments with other members of the team.
Requirements
Qualifications:
Candidate must possess at least Bachelor's/College Degree in Pharmacy/Pharmacology or equivalent.
Licensed Pharmacist
Willing to under go training
Willing to work in Bagong Ilog Pasig City
Can start immediately.
AMB HK Enterprises
Initial, renewal, maintenance of all e-portal accounts of AMB HK Enterprises Inc., PhilRx Pharma Inc. and FSPC Pharmaceuticals Inc.
Initial, renewal, variations and maintenance of all LTO (License to Operate) of AMB HK Enterprises Inc., PhilRx Pharma Inc. and FSPC Pharmaceuticals Inc.
Attend and facilitate FDA local inspections for AMB HK Enterprises Inc., and PhilRx Pharma Inc. Provide solutions and submit compliances based from the inspection report given by the FDA.
Attend and facilitate FDA foreign GMP inspections for AMB HK Enterprises Inc. Provide solutions and submit compliances based from the inspection report given by the FDA.
Initial, renewal, variations and maintenance of all GMP and permit to register of AMB HK Enterprises Inc., PhilRx Pharma Inc. and FSPC Pharmaceuticals Inc.
Inquire for quotation, prepare product and documents to conduct potency assay, bioavailability and clinical trials from CEDRES / UP IPS.
Application for importation certificates for regulated drugs in PDEA (Philippine Drug Enforcement Agency).
Application for importation certificates for food supplements in SRA (Sugar Regulatory Authority).
Initial CPN (Certificate of Product Notification) application for Cosmetics.
Foreign agreements with drug manufacturers under AMB HK Enterprises Inc., PhilRx Pharma Inc. and FSPC Pharmaceuticals Inc.
Local distributorship agreements for clients with other members of the team.
Sales promotion applications of AMB HK Enterprises Inc., PhilRx Pharma Inc. and FSPC Pharmaceuticals Inc.
IPO registration, publication, declaration of actual use, varaitions, renewal and maintenance under AMB HK Enterprises Inc., PhilRx Pharma Inc. and FSPC Pharmaceuticals Inc.
Initial, renewal, variations and maintenance of CLIDP (Baby CPR) applications.
Renewal applications and validity extensions of Drug PCPR (Mother CPR) .
Application for brand name clearances.
Draft labels for artworks together.
Major, minor and notification variation applications.
Provide necessary support such as regulatory information and answer queries of other departments for the benefit of AMB group of companies.
Field work as official business for the purpose of application submissions and FDA related transactions in FDAC Alabang, CEDRES, UP, PDEA, and SRA.
Notarize IAFs, draft letters, emails, request payments, brand name clearances of the applications.
Attend clients' requests in mail
Solving major to minor concerns and problems of clients and other departments with other members of the team.
Requirements
Qualifications:
Candidate must possess at least Bachelor's/College Degree in Pharmacy/Pharmacology or equivalent.
Licensed Pharmacist
Willing to under go training
Willing to work in Bagong Ilog Pasig City
Can start immediately.
AMB HK Enterprises
Other Info
Pasig City, Metro Manila
Permanent
Full-time
Permanent
Full-time
Submit profile
AMB HK Enterprises
About the company
Position regulatory pharmacist recruited by the company AMB HK Enterprises at MetroManila, Manila, Pasig, Joboko automatically collects the salary of , finds more jobs on regulatory pharmacist or AMB HK Enterprises company in the links above
About the company