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22 hours ago Be among the first 25 applicantsThis range is provided by EPHealthcare. Your actual pay will be based on your skills and experience talk with your recruiter to learn more.Base pay rangeA$110,000.00/yr - A$140,000.00/yrDirect message the job poster from EPHealthcareVic/Tas Manager & Healthcare Specialist Recruiter at EPHealthcareSenior Regulatory Affairs Associate - Innovative Prescription MedicinesLead regulatory activities incl. Cat 1 submissions & NMAsBroad ANZ role supporting innovative prescription medicinesStep-up opportunity for ambitious Regulatory Affairs AssociateSenior Regulatory Affairs AssociateA fantastic opportunity exists for an experienced Regulatory Affairs professional to take ownership of regulatory strategy and compliance for an innovative product portfolio. This respected global healthcare business has a strong local footprint and a collaborative team culture.We are seeking an experienced Senior Regulatory Affairs Associate or a high-achieving Regulatory Affairs Associate ready to take the next step in their career.About the Role:In this broad ANZ role, you will lead regulatory submissions and provide strategic support across the full product lifecycle. Youll work closely with internal and external stakeholders to ensure timely approvals and ongoing product compliance, with a focus on innovative medicines that improve patient outcomes.Key Responsibilities:Prepare and manage a wide range of regulatory submissions, including Category 1 applications and New Medicine Applications (NMAs)Provide expert input on clinical data and regulatory strategy for new and existing productsDevelop, review and maintain Product Information (PI), Consumer Medicine Information (CMI), labels, and supporting documentsEnsure timely, high-quality responses to regulatory authority queriesProvide regulatory and quality advice to internal teams and project stakeholdersSupport quality assurance activities for locally packaged and manufactured productsRepresent the organisation during regulatory authority interactions and auditsWhat Youll Bring:Tertiary qualifications in science, pharmacy, or a related fieldProven experience in regulatory affairs, ideally within the prescription medicines sectorStrong knowledge of regulatory requirements in Australia and New ZealandExperience with Category 1 submissions and interpretation of clinical dataExposure to quality assurance or manufacturing processes is highly desirableExcellent communication skills with the ability to manage complex projectsHigh attention to detail and ability to work independentlyWhy Join?Work with innovative medicines that make a difference in healthcareBroad, autonomous role with exposure to the full product lifecycleCollaborative, supportive team environmentCompetitive salary package including performance bonusNext StepsIf you are interested in this great opportunity please submit your application via the link. If you have any questions or would like to have a discussion around your job search, please call Donna Walker on 0418656131.Please follow us on our LINKEDIN page; EPHealthcareWhy work with EPHealthcare?Specialists in recruitment in Pharmaceutical and Medical DevicesOutstanding network of clientsThorough knowledge of the Healthcare industryIndustry experience - as reps, managers, marketers!Personalised and experienced approach, every step of the interviewing process.This opportunity is only open to candidates who are eligible to work in Australia and hold the appropriate visa to work permanentlySeniority levelSeniority levelExecutiveEmployment typeEmployment typeFull-timeJob functionJob functionScience, Legal, and Quality AssuranceIndustriesPharmaceutical Manufacturing, Hospitals and Health Care, and Medical Equipment ManufacturingReferrals increase your chances of interviewing at EPHealthcare by 2xSign in to set job alerts for Regulatory Affairs Associate roles.Southbank, Victoria, Australia 1 week agoSenior Regulatory Affairs Associate - MelbourneMelbourne, Victoria, Australia 4 weeks agoRegulatory Start Up Associate II - AustraliaMelbourne, Victoria, Australia 1 week agoInhouse Clinical Research Associate - AustraliaMelbourne, Victoria, Australia 6 days agoMelbourne, Victoria, Australia 1 week agoRegulatory Affairs and Quality Assurance AdministratorMelbourne, Victoria, Australia 5 days agoSouth Yarra, Victoria, Australia 2 weeks agoMelbourne, Victoria, Australia A$100,000.00-A$120,000.00 1 week agoAssociate/Senior Associate - Public Law & Regulatory ComplianceMelbourne, Victoria, Australia 3 weeks agoSenior Manager Regulatory Affairs & StrategyAssociate / Senior Associate, Superannuation - RegulatoryMelbourne, Victoria, Australia 2 weeks agoMelbourne, Victoria, Australia A$100,000.00-A$140,000.00 3 weeks agoMelbourne, Victoria, Australia 2 weeks agoMelbourne, Victoria, Australia 2 weeks agoMelbourne, Victoria, Australia 3 weeks agoMelbourne, Victoria, Australia 2 weeks agoClinical Research Associate II, Melbourne basedMelbourne, Victoria, Australia 2 weeks agoSouth Yarra, Victoria, Australia 1 week agoMelbourne, Victoria, Australia 9 hours agoClinical Research Associate II/ Senior Clinical Research AssociateMelbourne, Victoria, Australia 1 week agoMelbourne, Victoria, Australia 2 weeks agoMelbourne, Victoria, Australia 22 hours agoSenior Clinical Research Associate I (SCRA1), FSP modelMelbourne, Victoria, Australia 1 week agoWere unlocking community knowledge in a new way. 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