MA JESUSA SAN MIGUEL
Regulatory Officer
Summary
For the passed 10 years as a Licensed Pharmacist in different field of Pharmacy. I have gain knowledge and experiences, that I believe makes me more competitive and experienced Regulatory Officer. With over 5 years of experience in this regulatory field, from preparing of document requirements, submission of application as well as compliances and follow ups to meet the timeline given.
Overview
9
9
years of professional experience
11
11
years of post-secondary education
3
3
Certifications
Work History
License Compliance Manager
Acuherb Mktg International Corporation
Makati
01.2021 - 09.2021
- Handles all government requirements with regards to company compliance in FDA, BIR and all related government compliance permits.
- Securing pertinent documents related to business permits to meet given timeline.
- And Regulatory Officer functions and responsibilities
Regulatory Officer
Acuherb Mktg International Corporation
Makati
01.2017 - 01.2021
- Responsible for initial and renewal FDA application either license or product registrations.
- Preparing and filling all documents needed for product registration for compliances.
- Prepare and submit all the documents for hospital and trade inclusions or accreditations.
Company Pharmacist
Acuherb Mktg International Corporation
Makati
10.2015 - 01.2017
- Responsible in FDA initial and renewal applications.
- Update all the product record books and all documents needed for FDA routine inspections.
- Product inclusions and accreditations either hospitals or trade.
- Handles product knowledge trainings for Medical Sales Representative of the company.
- Attend MD's and patients inquiries in our Facebook account with regards in our product.
Store Pharmacist
South Star Drug Inc.
Quezon City
04.2013 - 05.2015
- Responsible for day to day store operations. And update record book with accordance to FDA regulations and requirements.
- Interpret prescription orders, dispensed medications and counseled patients on drugs.
- Recommend other generic alternatives.
Sterile Area Pharmacist
Euro- Med Laboratories Phil., Inc.
Dasmarinas
04.2012 - 09.2012
- Checks the raw materials and secure result of analysis prior to production.
- Supervises operators and production workers during production to ensure that all the process are being carried out to meet deadline and production quota.
- Participates in in-process checking for product quality.
- Prepares all documents related to the production.
- Ensure that all GMP are being implemented.
Licensed Pharmacist
The Generics Pharmacy
Quezon City
03.2011 - 01.2012
- Responsible for day to day store operations. And update record book with accordance to FDA regulations and requirements.
- Interpret prescription orders, dispensed medications and counseled patients on drugs.
- Recommend other generic alternatives.
- Participates in sales and promotions of product available in the store.
Education
Bachelor of Science - Pharmacy
Manila Central University
EDSA, Caloocan 06.2007 - 03.2010
Bachelor of Science - Industrial Engineering
New Era University
Quezon City 06.1996 - 03.2001
High School Diploma -
Sauyo High School
Quezon City 06.1992 - 03.1996
Skills
Correct medication dispensing & patient counseling
Certification
Implementation of AO #56 s.1989 Licensing of Drug Outlets, FDA Regulation Division 1
Timeline
License Compliance Manager
Acuherb Mktg International Corporation
01.2021 - 09.2021
Regulatory Officer
Acuherb Mktg International Corporation
01.2017 - 01.2021
Company Pharmacist
Acuherb Mktg International Corporation
10.2015 - 01.2017
Store Pharmacist
South Star Drug Inc.
04.2013 - 05.2015
Sterile Area Pharmacist
Euro- Med Laboratories Phil., Inc.
04.2012 - 09.2012
Licensed Pharmacist
The Generics Pharmacy
03.2011 - 01.2012
Bachelor of Science - Pharmacy
Manila Central University
06.2007 - 03.2010
Bachelor of Science - Industrial Engineering
New Era University
06.1996 - 03.2001
High School Diploma -
Sauyo High School
06.1992 - 03.1996
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