Regulatory Associate | Onsite | Ortigas | Night Shift

Advancing Global Wellness Through Compliance and Care Our 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 Description As 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 Overview Employment type: Full-timeShift: Night Shift, Weekends OffWork setup: Onsite (Megatower, Ortigas) Exciting Perks Await Day 1 HMO coverage with free dependent Competitive Salary Package Night differential pay to maximize your earnings Prime office location in Ortigas (Easy access to MRT stations, restaurants, and banks) Fixed weekends off Salary 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 ) 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 organization Standard government and Emapta benefits Total of 20 annual leaves to be used on your own discretion (including 5 credits convertible to cash) Fun engagement activities for employees Mentorship and exposure to global leaders and teams Career growth opportunities Diverse and supportive work environment The Qualifications We Seek Bachelor's degree in Engineering, Pharmaceutical, Life Sciences, or other related technical field 3+ years of experience developing and successfully defending complex regulatory submissions for medical devices and drugs Responsibilities include providing administrative support and managing communications (including calls) for international clients in the EU, US, Canada, and other regions Proficiency in Microsoft Excel and data analysis tools Highly analytical with a sharp eye for detail Eager to learn, adaptable, takes initiative, and aligned with business goals Excellent communication skills, both verbal and written Preferred Qualifications: ASQ or other regulatory certification Ability to self-motivate and drive results Experience interacting with EU, FDA, and other international regulatory bodies (including Health Canada) Project management experience Professional regulatory affiliations such as RAPS Your Daily Tasks Assist 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 expansions Perform reviews of existing and new product labeling claims to verify accuracy, substantiation, documentation, and compliance with applicable regulations Assist with the creation and maintenance of Declarations of Conformity and Technical Files on a quarterly basis Assist with the creation and maintenance of Technical File documents such as Post-Market Surveillance and Clinical Evaluation Reports Collaborate with EU and Swiss Authorized Representatives to report field actions and update technical files and declarations of conformity Provide support for determining medical device and drug classification in global markets Assist with global regulatory submission activities to secure market clearances, registrations, and licenses for medical devices and drug products Prepare 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 markets Assist with creation and maintenance of US Rx medical device and OTC drug licenses, and US law labels Other Duties and Responsibilities Support overall business goals through proactive regulatory intelligence and compliance strategy execution Collaborate cross-functionally to ensure regulatory documentation supports ongoing product quality and safety initiatives Maintain meticulous recordkeeping for audit readiness Key Performance Indicators (KPIs) Maintain a 98% or higher accuracy rate in preparing and submitting regulatory documents, ensuring all filings meet applicable agency requirements and timelines Ensure 100% of required submissions (renewals, variations, registrations) are completed and submitted on or before internal and external deadlines Achieve zero major findings in internal or external regulatory audits through consistent adherence to documentation standards and proactive compliance monitoring Welcome 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 #J-18808-Ljbffr