Regulatory Affairs Associate - Hybrid/Pharma/Contract

Orion Group Life Sciences are currently recruiting a Regulatory Affairs Associate on behalf of our Multinational Biopharmaceutical Client based inBuona Vista, Singapore onan initial12-Month contract with potential to extend. Hybrid role. Key responsibilities Manageslow to medium impact(with respect to internal visibility, risk,complexityand criticality)submission projectsto ensurethetimelydelivery ofhigh qualitydossiersthat meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency. Acts as SubmissionManagementsupport toproject teams providing guidanceand communication of established submission processes and standards. Provides input toprojectpublishing timelinesand deliverables. Participates insubmission team meetings.Expedites, manages, and coordinates multiple concurrent interrelated activities for submission projects in the delivery of low to moderately complex published submissions within the required timelines.Anticipates obstacles andproposes solutions within the team. Coordinates submission publishing with offsite publishers/provides notificationto ensure resources are available to meet submission timelines. Prepares content planner for publishing and works with vendor to resolve publishing issues Facilitates the creation or procurement of submission contentdeliverablessuch ascover letters and forms Performs detailed quality reviews of published output to ensure compliance with Regulatory Standards and Health Authority guidance’sincludingverification ofcontent,bookmarks, hypertextlinksand tables of content inlow to moderately complexsubmissions.Facilitates team reviews. Contributes to the development ofoptimalbusiness processes andstandardswithin the department to ensurehigh levelsof customer support and to achievehigh qualitysubmissions.Contributes to the implementation of internal process and standards documents relating to publishing and publishing deliverables. Suggests and contributes to process improvements, includingchanges to software and business processes.Mayparticipateon internal project teams to update business software. Demonstrates ability to influence without direct authority. Builds andmaintainspositive relationships internally and externally. Qualifications Bachelor’s degree PMP and RAC certificates desirable. Competencies Pharmaceutical or industry related experience Experience working in acomplex and matrix environment Strong communicationskills both oral and written Experience in Regulatory Affairs preferred but may consider QA, R&D/support, Scientific affairs,operationsor related area Experience in Regulatory Operations, including regulatory submission project management and/or submission publishing is preferred. #J-18808-Ljbffr