Regulatory Affairs Pharmacist

Julie Anne Moneva-Dequit

Home Address: **** ***** * ********* ***** C5 Northbound Taguig City

Contact numbers: +63-925*******

Email address: acpuv5@r.postjobfree.com

LinkedIn: acpuv5@r.postjobfree.com

Skype Username: julieannemoneva

SUMMARY

A Licensed Pharmacist in the Philippines with over 8 years relevant experience in the Pharmaceutical Industry

mainly dealing with Quality Control and Regulatory Affairs. Have almost 2 years experience as a

Chemical Analyst in a Manufacturing Company under Quality Control Department handling various laboratory

equipment such as HPLC, FTIR and UV-Vis Spectrophotometer for performing Process Validation, In-

Process Quality Controls & Chemical Assays of Raw materials and Finished p roducts. Had been oriented and

trained with Good Manufacturing Practice in the Chemical Laboratory for manufacturing Large Volume and

Small Volume parenterals. Gained a cumulative 6-year professional Regulatory experience in the Philippine

Pharmaceutical Industry setting for Registration, Licensing, Post-Market Surveillance Clinical Trials &

Pharmacovigilance for Drug, Medical Device, Cosmetics and Food Products.

Working on a Regionally-controlled Institutions, had actively participated in a Regional Meeting of Hyphens

Pharma Group of Companies in Singapore which hatched a productive Joint Discussions on the

Registration Processes and Challenges under ACTD faced by ASEAN countries such as Singapore, Malaysia,

Vietnam and Philippines.

Working on a Global platform, Lundbeck integrated core competencies and skills for outlining registration

timelines, compliances, good regulatory practices which is guided by a strict code of conduct and ethics.

Working with team-oriented institutions ripened my Interpersonal skills but can be highly independent at the

same time. Organized. Resourceful. Quick Learner.

QUALIFICATIONS

EDUCATION

March 2006 CENTRO ESCOLAR UNIVERSITY- Mendiola, Manila

Bachelor of Science in Pharmacy

July 2006 Pharmacy Licensures Exam-Board Passer

Professional Regulatory Commission

INTERNSHIPS

2004 Mercury Drugstore Corporation – Jaka Plaza, Sucat Paranaque

2004 Ospital ng Maynila – Qurino Ave., Manila

2005 Euro-Med Laboratories- Dasmarinas, Cavite

2005-2006 UP-Philippine General Hospital – Taft Avenue, Manila City

WORK EXPERIENCE

: Lundbeck Philippines, A Department of Metro Drug Inc- Makati City

Company Name

1.

: Regulatory Affairs Pharmacist & Technical Trainer

Position Title

: Manager

Position Level

: Regulatory Affairs / Technical

Specialization

: Pharmaceuticals (Importer/ Distributor)

Industry

: January 2013 up to May 2015

Date Joined

Regulatory Affairs Function

Compilation and submission of products initial registration, renewal, amendment applications,

indications or formulations to the relevant Regulatory Authorities, ensuring that registration

requirements are fulfilled so that registration may be obtained as quickly as possible.

Monitors follows up and reports on progress of regulatory submissions.

Responsible for activities relating to dossier maintenance for products, which have received regulatory

approval. .

Coordinates with Company Headquarter (Denmark) and Region (Singapore)

Pharmacovigilance – responsible for the monitoring, handling and reporting of any Adverse Reaction

or Serious Adverse reaction to the Medical Consultant, Regional office and Philippine Food and Drug

Administration.

Supervises Patient Compliance Program.

Initiates and renew product inclusion in various hospitals.

Technical Trainer.

: Hyphens Pharma. Philippines Inc.- Quezon City

Company Name

2.

: Regulatory Affairs Pharmacist & Medical Affairs Associate

Position Title

: Manager

Position Level

: Regulatory Affairs / Technical

Specialization

: Pharmaceuticals (Importer/ Distributor)

Industry

: January 2010 up to November 2012

Date Joined

Work Description

Regulatory Affairs Function

Compilation and submission of products initial registration, renewal, amendment applications,

indications or formulations to the relevant Regulatory Authorities, ensuring that registration

requirements are fulfilled so that registration may be obtained as quickly as possible.

Monitors follows up and reports on progress of regulatory submissions.

Responsible for activities relating to dossier maintenance for products, which have received regulatory

approval.

Develops draft labelling for registration packages, updates current labeling, reviews artwork relating to

products in line with the Company labelling within stipulated timelines according to FDA Philippines

using Adobe Illustrator and Adobe Photoshop Program.

Coordinates with Company Headquarter (Singapore) and Principal suppliers at all aspects pertaining to

product registration.

Works in close collaboration with Manufacturing counterparts and product Principals within the

Company to ensure the efficient and consistent execution of strategic regulatory plans of Hyphens

Pharma. Philippines portfolio and be accountable for regulatory compliance within the area of

responsibilities.

Drug Evaluation and screening activities:

Knowledge in handling ICH CTD coming from France, U.K., Belgium, Italy and Spain.

Arranging ICH-CTD documents according to ACTD dossier or Philippine National Guidelines for New

Drug Registration and Me-too products as Prescription Drugs.

Reviews ICH –CTD dossier on Module 2: Quality Over-all Summary (QOS), Module 3: Drug Substance

(Control of Drug Substance and Open Part of the DMF) and Drug Product (Description and Composition

of DP, Pharmaceutical Development, Manufacture, Control of Excipients, Control of Drug Product,

Reference Standards, Container Closure System and Stability).

Submits ICH-CTD Module 4: Non-clinical Study Reports and Module 5: Clinical Study Reports if

the Product is a New Drug or New Chemical Entity in the Market.

Prepared Quality Over-All Summary according to Philippine QOS Format.

Handles Legal Documents and Certificates such as Foreign Agency Agreement, Certificate of

Pharmaceutical Product (CPP), Certificate of Good Manufacturing Practice (cGMP), ISO 13485 for

Medical Device, Certificate of Foreign Government (CFG), Free Sale Certificate (FSC) and Certificate of

Analysis for Raw Materials and Finished Products.

Arranging of CSDT according to Philippine National Guidelines for Medical Device (Specific Use and

Directions, List of Amount & Technical Specification of Raw Materials and Finished Products,

Manufacturing Process, Stability Studies, Biocompatibility and Risk Analysis).

Assist on compilation and checking of Product Information File (PIF) for Cosmetics.

Preparation of Documents and Letter of Compliance for Notice of Deficiencies.

Medical Affairs Function

Representative of the company to coordinate with the Medical consultant and Investigators for

Company initiated Clinical trials and Post-Market Surveillance study, initiated by Philippine Food and

Drug Administration for New Drugs in the Philippine Market.

Responsible for activities relating to the preparation, Pre- and Post- meeting and monitoring of the

propose Clinical Study Trial.

Responsible for the distribution, monitoring and collection of Clinical trial agreement, Case Report

forms, Consent forms and other necessary forms for the Clinical Study Trial to the Investigators.

Pharmacovigilance – responsible for the monitoring, handling and reporting of any Adverse Reaction or

Serious Adverse reaction to the Medical Consultant, Hyphens Pharma. Singapore Main office and

Philippine Food and Drug Administration.

Company Contributions

Facilitated renewal and Assist on Inspection of License to Operate for Food, Drug, Cosmetics and

Medical Devices.

Initiated documentation and initial monitored release application for drug registration on Curosurf.

Initiated documentation, initial monitored release application for drug registration and obtained

Certificate of Product Registration on Cervidil.

Initiated documentation and initial monitored release application according to ASEAN guidelines for

drug registration on Rupafin.

Initiated documentation, submission and obtain notification for Cosmetics of BioXtra Mouthrinse,

toothpaste, mouth gel spray and moisturizing gel .

Initiated documentation, application of initial, renewal registration and amendment of Monoclarium

for Drug.

Initiated documentation, application of initial, renewal registration and amendment of Sterimar Classic

and Biomatrix for Medical Device.

Attended 1st Regional Meeting of Hyphens Pharma Group of Companies in Singapore. Joint Discussion

on the Registration process and Challenges faced under ASEAN Registration by Singapore, Malaysia,

Vietnam and Philippines.

Facilitated the monitoring, initiation, collection and analytical data, with the supervision of the Medical

Consultant, the Company initiated clinical study for the drug Monoclarium entitled: Comparative Study

of two doses of Monoclarium® (Clarithromycin) Prolonged-Release Capsule in Patients with Acute

Rhinosinusitis.

Facilitated the proposal of the Company initiated clinical study for drug Piascledine entitled: Evaluation

of the efficacy and safety of Avocado and Soybean Oil Unsaponifiables (Piascledine®) 300mg capsule

in the treatment of Knee Osteoarthritis

Facilitated the proposal and submission of the Post Market Surveilance for drug Rupafin entitled:

Evaluation of the efficacy and safety of Rupatadine fumarate (Rupafin®) on Allergic conditions for

the treatment of Seasonal Allergic Rhinitis (SAR) and/or Chronic Idiopathic Urticaria (CIU).

Facilitated the proposal and submission of the Post Market Surveilance for drug Rupafin entitled:

Evaluation of the efficacy and safety of Dinoprostone a naturally occurring Prostaglandin E2

(Cervidil®) in initiating cervical ripening prior to induction of labor in women with unfavorable cervix

at term.

: Phil. Shin Poong Pharmaceutical Inc – Pasig City

Company Name

3.

: Company and Regulatory Affairs Pharmacist

Position Title

: Manager

Position Level

: Regulatory Affairs / Technical / Admin & HR / Marketing

Specialization

: Pharmaceuticals (Importer/ Distributor)

Industry

: February 2008 – December 2009

Date Joined

Work Description

Liaison officer.

Responsible for product registrations of import products from Korea.

Monitor company’s compliance with BFAD, Department Of Health, PHILGEPs, Bureau of Customs and other

related accreditations.

Administrative and HR Officer

Handles Medical Representative affairs. Deals with distributor concerns

Arrange and prepare requirements for hospitals and biddings.

Conducts Product presentations and product trainings;

Supervise and monitors delivery and various logistics activities

Company Contributions

Re-organization and stabilization of the company’s renewed Standard Operating Procedures;

Implemented the use of outsourced delivery through logistics partners WWW Express and Lite Express;

Pioneered the innovation and full potential usage of the Shin Poong System, similar to SAP accounting system;

Supplied detailed information of the ASEAN Harmonization to Shin Poong Headquarters in Korea.

: Euro-med Laboratories - Dasmariñas, Cavite

Company Name

4.

: Chemical Analyst

Position Title

: Laboratory Associate

Position Level

: Quality Control Analyst

Specialization

: Pharmaceuticals (Manufacturing)

Industry

: August 2006 – February 2008

Date Joined

Work Description

Performs chemical analyses of finished products, chemical raw materials, stability samples, process validation

samples and in-process quality control testing/s;

Conducts research on the development of test methods of other related topics for the chemical division;

Trained to operate various laboratory equipments such as, HPLC, FTIR, AAS, TOCA, GC, UV-VIS

spectrophotometer and others as necessary tools in performing assigned tests, calibration, performance check and

maintenance;

Follows good manufacturing practice;

Observes proper documentation on protocols, analysis reports and validation forms.

SKILLS

Organized Flexible Fast-Learner

People-oriented Good Researcher

Multi-tasked Independent

Computer skills: Proficient in the use of Microsoft Office (Word, Excel, Powerpoint, Outlook and Publisher),

Software Applications for Design ( Adobe Illustrator and Adobe Photoshop), Software Application for Movie

Presentations ( Power Director and Windows Movie Maker).

PERSONAL INFORMATION

Birth date : July 12, 1985

Civil Status : Married

Religion : Roman Catholic

PRC no. : 0053266 Expiry: 12 July 2016

SSS number. : 340-***-****

T.I.N. : 303-379-270

Philhealth no. : 010*********

Pag-ibig no. : 011*********

Passport No. : EC2677679 Expiry: 09 November 2019

ACTIVITIES AND SEMINARS

Campus activity

President of Pharmacy Student Council, Batch 2005-2006

Over- all chairman of Pharmacy Leadership Training Seminars-2005;

Student volunteer in Community Outreach Programs and University Medical Missions;

Active member of Junior Philippine Pharmaceutical Association-beta chapter

Seminars Attended

• November 2008 ASEAN Harmonization on Pharmaceutical Product Registration

• February 2011 1st Regional Meeting of Hyphens Pharma Group of Companies, Singapore

• March 9-10 2011 Good Clinical Practice: Converging Clinical Trials in the Philippines

• May 3 2012 PAMDRAP: Training and Updates on Medical Device under National Guidelines

• May 2013 Good Regulatory Practice: Global Regulatory framework in CPH, Denmark

• March 2014 Asia RA PV Partners collaboration, KL, Malaysia

June 2014 1st ISOP-UMC Ensuring safe medicines underpins International Pharmacovigilance

•

• August 2014 Code of Conduct Cascade

RECOMENDATIONS

Stella Ang Bindoo Chahal Joan Alvarez

Regional Regulatory Affairs Manager Regional Director, Regulatory Affairs Country Manager

Hyphens Pharma Pte. Ltd-Singapore Lundbeck Lundbeck Philippines

(+65) 98481590 +60-123****** +632-***-****

acpuv5@r.postjobfree.com acpuv5@r.postjobfree.com acpuv5@r.postjobfree.com

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