OverviewClinigen, a rapidly growing global specialty pharmaceutical services business, is seeking a detail-oriented and motivated Regulatory Associate to join our dynamic team.
In this role, you will play a vital part in supporting the regulatory activities across Clinigen's portfolio, helping ensure that our products meet the highest standards of compliance and regulation.This is an excellent opportunity for someone looking to grow their career in regulatory affairs and make a significant impact within a globally recognized organization.ResponsibilitiesAssist in the preparation and submission of regulatory documentsMaintain up-to-date records and provide support for regulatory inquiriesWork closely with the Regulatory Affairs team and other departments to facilitate timely delivery of projects and ensure regulatory submissions are accurate and completeContribute to ensuring compliance with regulatory requirements across Clinigen's portfolioQualificationsBachelor's degree in Life Sciences, Pharmaceutical Sciences, or a related field4+ years of experience in regulatory affairs or a related field within the pharmaceutical or healthcare industryDemonstrated experience in a regulatory role servicing Australia and New ZealandKnowledge of TGA and Medsafe; other APAC regulatory knowledge is desirableeCTD publishing experience is desirableStrong attention to detail and ability to manage multiple tasks effectivelyExcellent written and verbal communication skillsProficient in Microsoft Office Suite and ability to learn new software efficientlyTeam player with a collaborative approach and strong interpersonal skillsAbility to work in a fast-paced environment and adapt to changing prioritiesBenefitsCompetitive remunerationAnnual performance bonusFlexible working arrangementsOngoing support for professional developmentPaid parental leaveOnsite parking
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