Dominique Ojadas

Experience

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  Zydus Philippines Inc.

  Jan 2011 - Sept 2011

  Regulatory Affairs Assistant

  Act as a liaison between the company and government agencies such as FDA, PDEA, IPO, GS1 and DENR-EMB.Ensure that company operations are compliant with the existing regulations of FDA.Ensure the validity of LTO and Certificate of Product Registrations.Facilitate product registrations with FDA (from dossier collation and review to registrations; amendments and renewals)Coordinate with partners local and abroad on issues concerning dossiers, samples and other technical concerns.Facilitate Bureau of Custom clearance in FDA.Facilitate dangerous drugs applications in PDEA.Facilitate barcode applications in GS1.Facilitate trademark applications and patent research in the Intellectual Property Office.Provide technical support to all concerned principals.Submit reportorial requirements on a regular basis.Ensure that product files and all legal documents are always updated and in order. Show less

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  Dynasty Pharmaceuticals

  Mar 2012 - Apr 2013

  Regulatory Affairs Pharmacist

  Represents the company in dealing with government agencies, particularly with the Food and Drug Administration and the Department of Health, specifically with the Center for Device Regulation, Radiation Health, and Research.Evaluates, collates and organizes manufacturing dossiers of products (i.e. drugs, cosmetics, medical devices and food products) prior to initial registration, renewals, amendments and other applications.Review of relevant scientific and legal documents for all registration purposes.Ensures that quality standards are met by the products being registered.Adheres to strict deadlines and submission of requirements.Coordinates and negotiates with FDA personnel with regards to pending registrations and statuses of applied products, etc.Ensures that all company licenses are up-to-date and valid.Makes sure that company operations are within current FDA regulations and guidelines.Maintains familiarity with company products and expiry dates of CPR’s to ensure timely renewals and other relevant applications, in order to sustain the flow of company business operations.Planning, undertaking and overseeing company compliance with regulatory inspections.Provides information, instructions and guidance to manufacturers and product distributors of the company regarding FDA regulations and requirements for registrations and other guidelines.Maintains regular communication with company manufacturers and product distributors regarding the progress of registrations and other requirements for applications.Prepares and updates Standard Operating Procedures within the Regulatory department and warehouse activities.Prepares and documents Product Complaint Forms, and communicates complaint to concerned manufacturers or distributors.Regularly inspects warehouse compliance with company SOP.Provides support to the Sales Team regarding product inclusion applications and for Hospital bidding requirements. Show less

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  Brenntag Ingredients Inc.

  May 2013 - Feb 2022

  Regulatory Affairs Officer

  Works on FDA, EMB, PDEA, BAI, SRA and PNP related applications. Adheres to strict deadlines in the application of permits, clearance and licenses.Ensures that company activities are compliant to the ever-changing regulations of all agencies stated-above.Maintains the validity of various licenses, certificates, permits and clearances. Makes sure that all importations of the company have the proper permit, clearance or license prior to the shipment of the product. Act as consultant to various Business Units in the company with regards to their importation of Food, Pharma and Personal Care products, and all types of industrial chemicals.Properly coordinates with the Supply Chain team and company brokers for appropriate action in relation to issues concerning Bureau of Customs.Supervises all inspections relevant to the maintenance of all company registrations. Prepares for government audits, third party audits, internal audits, customer audits and audits from the Regional Head Office.Makes certain that all procedures in the regulatory are followed and maintained as required under ISO 14001:2004 and OHSAS 18001:2007. Show less

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  STADA Philippines Inc.

  Mar 2022 - Feb 2024

  Regulatory Affairs Manager

  1) REGULATORY -Registration and Maintenance of Licensesa. Manage/ oversee all regulatory activities (registrations, renewals, and variations) in line with FDA requirements, regulatory/ supply constraints, and BU launch plans, in close collaboration with global and regional regulatory team.b. Act as key interface between company and FDA for all regulatory matterscontactsd. Apply regulatory and pharmaceutical knowledge to FDA regulations to provide correct product dossier and ensure validity of certificates and availability of the products in the market.e. Represent regulatory in cross- functional meetings to anticipate/resolve regulatory concerns and provide regulatory inputs and strategies in line with business objectives.f. Coordinate the preparation of company position papers with appropriate experts as appropriate and develop an adequate action plan to address key regulatory issuesg. Work in close collaboration with supply chain and other appropriate functions to avoid any supply interruptions in assigned countries2. PRODUCT DEVELOPMENTa. Assess the regulatory impact and requirements for product changes and define the priority of variation submissions.b. Provide guidance, advice and communicate technical, regulatory, and quality information relevant to product development with respect to their implications in business, and during development of promotional materials and detailing aids.c. Bring appropriate regulatory expertise and develop regulatory strategy to business projects3. 4. NETWORKING AND REGULATORY INTELLIGENCEa) Build strong working relationships with key stakeholders (internal and external) and ensure optimal communication flow with key stakeholders.b) Ensure representation of company in local regulatory working groups/ consultation as appropriate.c) Keeps abreast of country’s regulatory activities and legislations to address potential risks. Show less

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  Glenwood Services Philippines Inc.

  Mar 2024 - now

  Regulatory Affairs Manager

  • Maintenance of drug marketing authorisations in Drug Regulatory Affairs (DRA) in accordance with drug legislation and other local legal requirements.• Coordination of marketing authorisations and submissions to government agencies (i.e.xFDA, national authorities) and management of approval-relevant processes via local RA partners • Preparation of relevant marketing authorisations documents for obtaining and maintaining marketing authorisations (national/international)• Definition of requirements for the renewal and variation of marketing authorisations of medicinal products, taking into account national and international requirements.• Preparation of submission sequences for the renewal and variation of marketing authorisations at national and international level, as well as submission via the respective submission platforms of national competent authorities• Preparation, modification and review of legal product information, taking into account the German Medicinal Products Act and other regulatory requirements and national laws.• Support in the creation of mock-ups and review of drug texts or legal product information, taking into account the German Medicines Act and other regulatory requirements• Recording and evaluation of expert opinions, guidelines, regulations, announcements, etc. related to the approval of medicinal products• Monitoring global regulatory environment • Participation in projects for the smooth transfer/reassignment of marketing authorisations (MAT) in the context of the sale of MA and cooperation with license partners/former MA holders within the framework of the project• Development of country-specific variation time schedules for the respective MA, e.g. within the framework of MATs (incl. period and costs) and monitoring of their timing• Cooperation, consulting, maintaining contacts and exchanging experiences with all departments and contractual partners involved in regulatory affairs-relevant processes Show less