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Address: 39-A Columbia St. Cubao, Quezon City,1109 Philippines* mobile: +639175281487 * email: cong1@its.jnj.com
Celia L. Ong, RPh
PROFEESIONAL SUMMARY:
Independent, self-driven, hardworking individual with 18 years of experience on government agency as Food and
Drug Regulatory Officer in the field of pharmaceuticals and cosmetics. With more than 6 years of experience on
private company as associate manager for regulatory affairs, Asia Pacific.
My previous experiences have instilled in me the value of building strong relationships with clients, providing a
good relationship with the different cultures and give satisfaction on the services required, maintaining an organized
and streamlined operation of the system and processes in place and has the ability to work with the team and
understand the importance of communication.
Education [1991- 1992] University of Santo Tomas Espana, Manila
Master of Pharmacy- earn 9 units
[ 1982- 1987] Centro Escolar University Legarda, Manila
B. S. Pharmacy- 5 year Curriculum
Skills and [1987] Pharmacy Licensure Exam
Abilities
[ 2006] Vrije Universiteit Brussel/EC/ASEAN
Safety Assessment of Cosmetics course in EU
Skills: Computer literate- Word Processing ; Excel/Spreadsheet; PowerPoint; Project Management
Others- athletic skills and research
Seminars and Trainings
[Nov. 15-18, 2016] 25th
ACSB/ACC Meeting Brunei Darussalam
[Oct. 26, 2016] Seminar on the Guiding Principles of Cosmetics CCIP, Manila
Products Claims & Claim Substantiation
[June 22-23, 2016] Training on GMP for cosmetic products with CCIP, Davao City
workshop on creation and development
on PIF & Protocols on Product Safety Assessment
[June 17, 2016] FDA Training on Cosmetic Claims JnJ Sponsorship
and Substantiation Acacia Hotel, Alabang, PH
[May 24-27, 2016] ASEAN Meeting Hanoi, Vietnam
[ Apr. 26. 2016] Technical Training on cosmetic safety, J&J Instructor Led- webex
quality, efficacy assessment,
PMS handling to AP RA
[Apr. 18, 2016] EGI DD Training J&J Instructor Led- webex
[ Apr. 6, 2016] Seminar on Laboratory Testing for Chamber of Cosmetic
Cosmetic Products and Packaging Industry of the PH (CCIP)
[ Nov. 25-27, 2014] ASEAN Meeting Philippines
[ Aug. 14, 2014] Product Exportation and its Regulation CCIP
on Finished Goods
[ Nov. 25-27, 2015] ASEAN Meeting Thailand
[ Aug. 12, 2015] Packaging and Marketing Trends Seminar CCIP
[ June 17, 2015] Product Safety Assessment, GMP and CCIP
PIF seminar
[ May 26-29, 2015] ASEAN Meeting Singapore
[May 24-26, 2011] Claims training J&J Seoul, Korea
[Mar. 21-25, 2011] Orientation on Skincare Clinical Studies J&J Shanghai, China
Method and Evaluation
Affiliations: Philippine Pharmaceutical Association Member
Philippine League of Pharmacy Member
Chamber of Cosmetic Industry of the Phils. External Affairs, Vice-President
FDA Alumni, Incorporated Member
Work Experience:
[Aug. 2009- Johnsons & Johnson International Regional operating Headquarters
Present] (Singapore) Pte. Ltd. Edison Road, Bo. Ibayo, Paranaque
City
Associate Manager, Regulatory Affairs, AP
● Develop projects to make the process and system work efficiently
● Responsible in managing and monitoring the Regulatory Intelligence System and
provide reports
● Responsible for the review and approval of raw materials use in AP in optiva system
● Responsible for the review and approval of formulas for launch in AP in optiva system
● Responsible in the generation of Ingredient Listing for Artwork purposes
● Responsible in maintaining the PIF sharepoint for the marketed products in ASEAN
● Responsible in managing the performance and deliverables of outsourced contractors
● Responsible in updating the Guidelines and Restrictions of ingredients for AP
● Conduct and organize training on RAs and cross functional team related to process and
Requirements
● Drafted SOP and Process to ensure efficient and deliverables to the business
● Participated on different project related to system upgrading, regulatory requirements
And process improvement
● Contribute to regional and global discussion related to ingredient reviews for early
development projects in skincare
● Participate in the Technical Working Group for PH position on the ASEAN meeting
● Represent JnJ on Cosmetic association as part of the Board to position the business stand on
external engagement with Health authority and other government agencies
Regulatory Affairs Consultant, Consumer AP
● Assists Regional Regulatory Director in working closely with Local RA colleagues to
Support them in their regulatory activities
● Assists Regional Regulatory Director in identifying inefficiencies and putting in place system
and processes to enhance business efficiency and effectiveness
● Coordinate and monitor the development of the regulatory environment in the region and
globally to ensure compliance to market
● Maintain ingredient database used for formula and raw material review
● Help coordinate industry association related activities with guidance from the Regional
Regulatory Director
[1995- Food and Drug Administration, Philippines Alabang, Muntinlupa City
Aug. 2009
Food and Drug Regulation Officer III
● Evaluates product dossier on application for market authorization of cosmetic, household
hazardous and Pharmaceutical
● Conduct PIF audit on cosmetic establishments
● Conduct training and seminars on cosmetic regulation
● Review and drafts new policy on cosmetic and pharmaceutical regulation
● Represent the Philippines as the official delegate on the ASEAN cosmetic Scientific Body
(ACSB) and ASEAN cosmetic Committee (ACC) twice a year
● Provide responses to queries and letters concerning cosmetic regulation
● Conducts analysis on cosmetic and pharmaceutical products for registration
● Conduct validation process on methods for analysis
[1991- 1995] Food and Drug regulation officer II
● Evaluates product dossier on application for market authorization of
Pharmaceutical
● Evaluates application of pharmaceutical product with post approval changes
● Evaluates collected samples suspected to be counterfeit products
[1998- 1991] Medical City General hospital Ortigas, Pasig City
Staff Pharmacist
● Prepares, compound and dispense drugs to in-patient and out-patient
● Encodes drugs being dispensed to in-patient account
___________________________________________________________________________________________
Personal Nickname: Celia/Cel
Information Nationality: Filipino
Date of Birth: November 3, 1965
Civil Status: Married
Character References
Le, Chau Giang Vice President, Regualtory Affairs and Scientific Engagement
Johnsons and Johnsons International (Singapore) Pte Ltd.
Email: CLE1@its.jnj.com
Mobile: +6591019248
Alain Khaiat Seers consultancy, Singapore
Email: seersconsult@gmail.com
Mobile: +658199816
Ma. Lourdes C. Santiago OIC Director General
FDA, Philippines, Alabang, Muntinlupa City
Email: mlcsantiago@fda.gov.ph
Mobile: +639175421166

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CV of Celia Ong 2016

  • 1. Address: 39-A Columbia St. Cubao, Quezon City,1109 Philippines* mobile: +639175281487 * email: cong1@its.jnj.com Celia L. Ong, RPh PROFEESIONAL SUMMARY: Independent, self-driven, hardworking individual with 18 years of experience on government agency as Food and Drug Regulatory Officer in the field of pharmaceuticals and cosmetics. With more than 6 years of experience on private company as associate manager for regulatory affairs, Asia Pacific. My previous experiences have instilled in me the value of building strong relationships with clients, providing a good relationship with the different cultures and give satisfaction on the services required, maintaining an organized and streamlined operation of the system and processes in place and has the ability to work with the team and understand the importance of communication. Education [1991- 1992] University of Santo Tomas Espana, Manila Master of Pharmacy- earn 9 units [ 1982- 1987] Centro Escolar University Legarda, Manila B. S. Pharmacy- 5 year Curriculum Skills and [1987] Pharmacy Licensure Exam Abilities [ 2006] Vrije Universiteit Brussel/EC/ASEAN Safety Assessment of Cosmetics course in EU Skills: Computer literate- Word Processing ; Excel/Spreadsheet; PowerPoint; Project Management Others- athletic skills and research
  • 2. Seminars and Trainings [Nov. 15-18, 2016] 25th ACSB/ACC Meeting Brunei Darussalam [Oct. 26, 2016] Seminar on the Guiding Principles of Cosmetics CCIP, Manila Products Claims & Claim Substantiation [June 22-23, 2016] Training on GMP for cosmetic products with CCIP, Davao City workshop on creation and development on PIF & Protocols on Product Safety Assessment [June 17, 2016] FDA Training on Cosmetic Claims JnJ Sponsorship and Substantiation Acacia Hotel, Alabang, PH [May 24-27, 2016] ASEAN Meeting Hanoi, Vietnam [ Apr. 26. 2016] Technical Training on cosmetic safety, J&J Instructor Led- webex quality, efficacy assessment, PMS handling to AP RA [Apr. 18, 2016] EGI DD Training J&J Instructor Led- webex [ Apr. 6, 2016] Seminar on Laboratory Testing for Chamber of Cosmetic Cosmetic Products and Packaging Industry of the PH (CCIP) [ Nov. 25-27, 2014] ASEAN Meeting Philippines [ Aug. 14, 2014] Product Exportation and its Regulation CCIP on Finished Goods [ Nov. 25-27, 2015] ASEAN Meeting Thailand [ Aug. 12, 2015] Packaging and Marketing Trends Seminar CCIP [ June 17, 2015] Product Safety Assessment, GMP and CCIP PIF seminar [ May 26-29, 2015] ASEAN Meeting Singapore [May 24-26, 2011] Claims training J&J Seoul, Korea [Mar. 21-25, 2011] Orientation on Skincare Clinical Studies J&J Shanghai, China Method and Evaluation Affiliations: Philippine Pharmaceutical Association Member Philippine League of Pharmacy Member
  • 3. Chamber of Cosmetic Industry of the Phils. External Affairs, Vice-President FDA Alumni, Incorporated Member Work Experience: [Aug. 2009- Johnsons & Johnson International Regional operating Headquarters Present] (Singapore) Pte. Ltd. Edison Road, Bo. Ibayo, Paranaque City Associate Manager, Regulatory Affairs, AP ● Develop projects to make the process and system work efficiently ● Responsible in managing and monitoring the Regulatory Intelligence System and provide reports ● Responsible for the review and approval of raw materials use in AP in optiva system ● Responsible for the review and approval of formulas for launch in AP in optiva system ● Responsible in the generation of Ingredient Listing for Artwork purposes ● Responsible in maintaining the PIF sharepoint for the marketed products in ASEAN ● Responsible in managing the performance and deliverables of outsourced contractors ● Responsible in updating the Guidelines and Restrictions of ingredients for AP ● Conduct and organize training on RAs and cross functional team related to process and Requirements ● Drafted SOP and Process to ensure efficient and deliverables to the business ● Participated on different project related to system upgrading, regulatory requirements And process improvement ● Contribute to regional and global discussion related to ingredient reviews for early development projects in skincare ● Participate in the Technical Working Group for PH position on the ASEAN meeting ● Represent JnJ on Cosmetic association as part of the Board to position the business stand on external engagement with Health authority and other government agencies Regulatory Affairs Consultant, Consumer AP ● Assists Regional Regulatory Director in working closely with Local RA colleagues to Support them in their regulatory activities ● Assists Regional Regulatory Director in identifying inefficiencies and putting in place system and processes to enhance business efficiency and effectiveness ● Coordinate and monitor the development of the regulatory environment in the region and globally to ensure compliance to market ● Maintain ingredient database used for formula and raw material review ● Help coordinate industry association related activities with guidance from the Regional Regulatory Director [1995- Food and Drug Administration, Philippines Alabang, Muntinlupa City Aug. 2009 Food and Drug Regulation Officer III
  • 4. ● Evaluates product dossier on application for market authorization of cosmetic, household hazardous and Pharmaceutical ● Conduct PIF audit on cosmetic establishments ● Conduct training and seminars on cosmetic regulation ● Review and drafts new policy on cosmetic and pharmaceutical regulation ● Represent the Philippines as the official delegate on the ASEAN cosmetic Scientific Body (ACSB) and ASEAN cosmetic Committee (ACC) twice a year ● Provide responses to queries and letters concerning cosmetic regulation ● Conducts analysis on cosmetic and pharmaceutical products for registration ● Conduct validation process on methods for analysis [1991- 1995] Food and Drug regulation officer II ● Evaluates product dossier on application for market authorization of Pharmaceutical ● Evaluates application of pharmaceutical product with post approval changes ● Evaluates collected samples suspected to be counterfeit products [1998- 1991] Medical City General hospital Ortigas, Pasig City Staff Pharmacist ● Prepares, compound and dispense drugs to in-patient and out-patient ● Encodes drugs being dispensed to in-patient account ___________________________________________________________________________________________ Personal Nickname: Celia/Cel Information Nationality: Filipino Date of Birth: November 3, 1965 Civil Status: Married Character References Le, Chau Giang Vice President, Regualtory Affairs and Scientific Engagement Johnsons and Johnsons International (Singapore) Pte Ltd. Email: CLE1@its.jnj.com Mobile: +6591019248 Alain Khaiat Seers consultancy, Singapore Email: seersconsult@gmail.com Mobile: +658199816 Ma. Lourdes C. Santiago OIC Director General FDA, Philippines, Alabang, Muntinlupa City