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
Regulatory filling and compliance per product registrations per FDA centers
Excellent in Communication and Interpersonal Skill
Proficient in Typing
Working Knowledge in MS Word, MS Excel, PowerPoint and POS (Point of Sales)
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