Regulatory Associate | Onsite | Ortigas | Night Shift

Type: Full TimeRegion: InternationalTown/City: Mandaluyong, National Capital RegionPosted: 23/10/2025Reference: JOB-1761199598_1761213214Job DescriptionAdvancing Global Wellness Through Compliance and CareOur client is a trusted leader in the health, wellness, and fitness industry, dedicated to improving lives through innovative medical and wellness products. Their commitment to quality, safety, and regulatory excellence drives their global expansion - ensuring that every product reaching the market meets the highest standards of health and efficacy.With operations spanning multiple regions, they continue to uphold integrity, innovation, and reliability in every solution, helping customers live stronger, healthier, and more empowered lives worldwide.Job DescriptionAs a Regulatory Associate, you will support global compliance and product registration efforts for health, medical, and wellness products. You'll ensure all documentation and labeling meet international standards while contributing to regulatory strategies that empower global health and safety.Job OverviewEmployment type: Full-timeShift: Night Shift, Weekends OffWork setup: Onsite (Megatower, Ortigas)Exciting Perks Await!Day 1 HMO coverage with free dependentCompetitive Salary PackageNight differential pay to maximize your earningsPrime office location in Ortigas (Easy access to MRT stations, restaurants, and banks)Fixed weekends offSalary Advance Program through our banking partner (Eligibility and approval subject to bank assessment. Available to account holders with minimum of 6 months company tenure.)Unlimited upskilling through Emapta Academy courses (Want to know more? Visit https://bit.ly/EmaptaTrainingCalendar)Free 24/7 access to our office gyms (Ortigas and Makati) with a free physical fitness trainer!Exclusive Emapta Lifestyle perks (hotel and restaurant discounts, and more!)Unlimited opportunities for employee referral incentives across the organizationStandard government and Emapta benefitsTotal of 20 annual leaves to be used on your own discretion (including 5 credits convertible to cash)Fun engagement activities for employeesMentorship and exposure to global leaders and teamsCareer growth opportunitiesDiverse and supportive work environmentThe Qualifications We SeekBachelor's degree in Engineering, Pharmaceutical, Life Sciences, or other related technical field3+ years of experience developing and successfully defending complex regulatory submissions for medical devices and drugsResponsibilities include providing administrative support and managing communications (including calls) for international clients in the EU, US, Canada, and other regionsProficiency in Microsoft Excel and data analysis toolsHighly analytical with a sharp eye for detailEager to learn, adaptable, takes initiative, and aligned with business goalsExcellent communication skills, both verbal and writtenPreferred Qualifications:ASQ or other regulatory certificationAbility to self-motivate and drive resultsExperience interacting with EU, FDA, and other international regulatory bodies (including Health Canada)Project management experienceProfessional regulatory affiliations such as RAPSYour Daily TasksAssist with maintaining global registrations and listings for establishments, medical devices, over-the-counter (OTC) drugs, and cosmetics - annually for renewals and monthly for new product launches and global market expansionsPerform reviews of existing and new product labeling claims to verify accuracy, substantiation, documentation, and compliance with applicable regulationsAssist with the creation and maintenance of Declarations of Conformity and Technical Files on a quarterly basisAssist with the creation and maintenance of Technical File documents such as Post-Market Surveillance and Clinical Evaluation ReportsCollaborate with EU and Swiss Authorized Representatives to report field actions and update technical files and declarations of conformityProvide support for determining medical device and drug classification in global marketsAssist with global regulatory submission activities to secure market clearances, registrations, and licenses for medical devices and drug productsPrepare and maintain global regulatory documents required to secure global licenses, registrations, and listings in a timely and cost-effective manner - including legalization and apostille of documents and obtaining FDA Certificates to Foreign Government (CFGs)Provide business support and expertise regarding regulatory requirements in global marketsAssist with creation and maintenance of US Rx medical device and OTC drug licenses, and US law labelsOther Duties And Responsibilities:Support overall business goals through proactive regulatory intelligence and compliance strategy executionCollaborate cross-functionally to ensure regulatory documentation supports ongoing product quality and safety initiativesMaintain meticulous recordkeeping for audit readinessKey Performance Indicators (KPIs):Maintain a 98% or higher accuracy rate in preparing and submitting regulatory documents, ensuring all filings meet applicable agency requirements and timelinesEnsure 100% of required submissions (renewals, variations, registrations) are completed and submitted on or before internal and external deadlinesAchieve zero major findings in internal or external regulatory audits through consistent adherence to documentation standards and proactive compliance monitoringWelcome to Emapta Philippines!Join a team that values camaraderie, excellence, and growth. Recognized as one of the Top 20 Dream Companies of Filipinos in 2024, Emapta stands proudly alongside industry giants, offering stability and exciting career opportunities. Your career flourishes here with competitive compensation, international clients, and a work culture focused on collaboration and innovation. Work with global clients across industries, supported by a stable foundation and like-minded professionals passionate about making an impact. We empower your success with opportunities for personal and professional development in an inclusive environment. Apply now and be part of the #EmaptaEra!Apply for this jobDiscover morePlant hire servicesCivil engineering servicesPlant equipment listingsBuilding materials suppliersConstruction legal servicesUK construction newsConstruction safety equipmentConstruction site welfare unitsConcrete testing equipmentConstruction news widget