Regulatory Affairs Pharmacist
Resume:
Kathrine A. Delima, RPh.
Blk * Lot ** Sunflower St., Rodriguez Village,
Lawa, Calamba City, Laguna
Contact No.: +63-939-***-****
Email: acp7z4@r.postjobfree.com
Employment History:
August 1, 2012 to present Swisspharma Research Laboratories, Inc.
Regulatory Affairs Pharmacist
Bo. Pittland, Cabuyao, Laguna
Acts as Company Pharmacist.
Acts as Liaison Officer to transact all the necessary requirements for
compliance with the Philippine Regulatory Agencies such as Food and Drug
Administration (FDA), Philippine Drug Enforcement Agency (PDEA), Bureau
of Animal Industry (BAI) and others.
Acts as a Qualified Person in Industry Regulatory Affairs for Drugs,
Cosmetics, Medical Device
Organize product dossiers and ensure they are comprehensive, properly
formatted, and conform to applicable regulatory requirements.
Provide Assurance (supports Certificates of Product Registration) that
products are of high quality and achieved conformity to the establish ed
standards of specifications.
Coordinates with the heads of concerned departments to monitor client
product development and product stability.
Coordinates QMD Manager in proper implementation of Quality System,
participates in cGMP, Safety and Responsibl e Care Programs.
Coordinates with the Research and Development team in developing new
products.
Internship:
October 2014 – December 2014 Philippine General Hospital
Taft Avenue, Manila
Clinical Pharmacy Intern
September 2010 – January 2011 Calamba Doctors Hospital
Parian, Calamba City, Laguna
Hospital (Major) Internship – 360 hours
June 2010 – August 2010 St. James Hospital, Inc.
Dita, Sta. Rosa City
Hospital (Minor) Internship – 200 hours
April 2010 – May 2010 Square Pharmaceuticals, Inc.
3428 East Service Road, Ups II, Parañaque City
Manufacturing (Minor) Internship – 200 hours
April 2008 – May 2008 Mercury Drug Corporation
Calamba Crossing Uno Branch
Crossing, Calamba City, Laguna
Community (Minor) Internship – 200 hours
Educational Background:
Philippine Women’s University
Post Graduate
Master of Science in Pharmacy with Specialization in
Clinical Pharmacy
Taft Avenue, Manila
S.Y. June 2013 – present
Tertiary University of Perpetual Help System DALTA
Bachelor of Science in Pharmacy
Leadership Award
Brgy. Paciano Rizal, Calamba City, Laguna
S.Y. 2008 - 2011
S.Y. 2007 – 2008
Secondary National University
Sigmanian (Honor) Student
M.F. Jhocson, Sampaloc, Manila
S.Y. 2006 – 2007
Primary University of Perpetual Help System DALTA
Best in Mathematics
Brgy. Paciano Rizal, Calamba City, Laguna
S.Y. 2001 – 2003
Skill/s:
Communications Skills
Analytical/Research Skills
Interpersonal Abilities
Solving/Reasoning/Creativity
Computer literate especially Microsoft Office (Word, Excel, Powerpoint, etc.)
Driving
Registration:
Registered Pharmacist
Registration No.: 0060861
July 2012
Affiliation:
Philippine Pharmaceutical Association (PPhA)
2012 to present – Member
Philippine Association of Pharmacist in the Pharmaceutical Industry (PAPPI)
2012 to present - Company Representative
Philippine Chamber of the Pharmaceutical Industry (PCPI)
2012 to present - Company Representative
Philippine Pharmaceutical Manufacturers Association (PPMA)
2012 to present - Company Representative
Seminars/Trainings Attended:
2nd General Membership Meeting
May 8, 2015
“Quality Risk Management: An Introduction and
Workshop for Industry, PRC Registration of Detailmen:
Introduction, Clarification & Issues Around It and FDA
Requirements on RMP”
By: Philippine Association of Pharmacists in the
Pharmaceutical Industry
Acacia Hotel Manila, Alabang, Muntinlupa City
April 22-26, 2015 2015 Philippine Pharmacist Association National
Convention
“Pharmacy Practice Standards: Based on Science,
Driven by Evidence”
SMX Convention Center Bacolod, Bacolod City, Negros
Occidental
Process Validation: “From design space to continuous
October 4, 2014
process improvement”
By: Ms. Sothie Jordan, QMD Manager of Swisspharma
Research Laboratories Inc.
AVR Swisspharma Research Laboratories Inc., Barrio,
Pittland, Cabuyao, Laguna
September 25, 2014 Good Manufacturing Practice on Complaints and
Product Recall – Module # 6
By: Philippine Pharmaceutical Manufacturers Association
Astoria Plaza Hotel, Pasig City
April 24-26, 2014 2014 Philippine Pharmacist Association National
Convention
“Access to Pharmacists, Access to Better Health”
SMX Convention Center, SM Lanang Premier, Bahada,
Davao City
1st General Membership Meeting
March 21, 2014
“PRC Updates and Developments, Pharmacy Law
Updates, Global Generic Market: The World and US, FDA
Updates and Developments”
By: Philippine Association of Pharmacists in the
Pharmaceutical Industry
Nathan Hall, Glaxo Smith Kline, Pasong Tamo, Makati City
Seminar/Workshop on the “Regulatory Control
March 14, 2014
Mechanism of Dangerous Drugs for S5C Holders”
By: Philippine Drug Enforcement Agency
PDEA Conference Room
“Orientation Seminar on Animal Feeds and Veterinary
January 23, 2014
Drugs and Products”
By: Bureau of Animal Industry
Visayas Ave., Diliman, Quezon City
Seminar on “Center for Food Regulation and Research
November 25, 2013
Good Manufacturing Practices for Food Manufacturers
and Traders”
By: Food and Drug Administration
Vivere Hotel, 5102 Bridgeway Ave., Filinvest Corporate City,
Alabang, Muntinlupa City
Seminar on “Center for Cosmetic Regulation and
November 19, 2013
Research 13 ASEAN Module and GMP for Cosmetic
Manufacturers and Traders”
By: Food and Drug Administration
AVR 3rd flr. FDA Annex Building, Civic Drive, Filinvest
Corporate City, Alabang, Muntinlupa City
14th P APPI Biennial Convention
November 8-9, 2013
“Regulatory Compliance for Better Health Outcomes”
Canyon Woods Resort Club, Brgy. San Gregorio, Laurel,
Batangas
Training on “Center for Drug Regulation and Research
September 23-24, 2013
Qualified Person in Industry Regulatory Affairs”
By: Food and Drug Administration
Vivere Hotel, 5102 Bridgeway Ave., Filinvest Corporate City,
Alabang, Muntinlupa City
Seminar on “Principles of Bioavailability/
July 10, 2013
Bioequivalence: A Practical Guide”
By: UST Center for Drug Research, Evaluation and Studies,
Inc.
RITM Auditorium, Alabang, Muntinlupa City
Training on “Qualified Person in Industry Regulatory
July 1-2, 2013
Affairs for Center for Food Regulation and Research”
By: Food and Drug Administration
AVR 3rd flr. FDA Annex Building, Civic Drive, Filinvest
Corporate City, Alabang, Muntinlupa City
April 25-27, 2013 2013 Philippine Pharmacist Association National
Convention
“The Filipino Pharmacists for Better Health Outcomes”
Philippine International Convention Center
Pasay City, Philippines
Training on “Center for Device Regulation, Radiation
April 4-5, 2013
Health and Research Qualified Person in Industry
Regulatory Affairs”
By: Food and Drug Administration
AVR 3rd flr. FDA Annex Building, Civic Drive, Filinvest
Corporate City, Alabang, Muntinlupa City
Seminar on “Advanced Pharmacovigilance and Risk
March 26, 2013
Management Planning for PV Officer”
By: Food and Drug Administration
AVR 3rd flr. FDA Annex Building, Civic Drive, Filinvest
Corporate City, Alabang, Muntinlupa City
Training on “Center for Cosmetic Regulation and
March 11-12, 2013
Research Qualified Professional in Regulatory Affairs”
By: Food and Drug Administration
AVR 3rd flr. FDA Annex Building, Civic Drive, Filinvest
Corporate City, Alabang, Muntinlupa City
Seminar on “Licensing and Registration Seminar for
October 30, 2012
Food Establishments”
By: Food and Drug Administration
AVR 3rd flr. FDA Annex Building, Civic Drive, Filinvest
Corporate City, Alabang, Muntinlupa City
September 27-28, 2012 Seminar on the Licensing of Establishment as per A.O.
56 s.1989 and A.O. 2012-008 “Adoption and
Implementation of Pharmaceutical Inspection
Cooperation Scheme (PIC/S) for the GMP for Medicinal
Products”
By: Food and Drug Administration
AVR 3rd flr. FDA Annex Building, Civic Drive, Filinvest
Corporate City, Alabang, Muntinlupa City
Character References:
Ms. Sothie Jordan
QMD Manager
Swisspharma Research Laboratories Inc.
Mely-Rose Molina
HR Assisstant/ Company Nurse
Swisspharma Research Laboratories Inc.
Maria Donnabella Castillo
College Professor
University of Perpetual Help System DALTA – Calamba Campus
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