This FSP Team - Senior RA Associate opening may need to go into Client's office 2-3 times a week.Location: MelbourneKey AccountabilitiesProject ExecutionPrevious experience working in industry in support of Global and/or local Regulatory teams, with comprehensive understanding of regional and global regulatory requirements, guidelines and processes and in-depth expertise on local health authority managementStrong knowledge of post-authorization lifecycle maintenance procedures e.g. variations, renewals, PSURs, etc, timelines and requirements, to support maintenance of multiple licenses, including management of HA interactions and responses to questionsUse of document management tools (internal systems) and external platformsPrepare, organize and coordinate local specific documentation e.g. module 1 to meet national submission requirements and be responsible for keeping up-to-date local national systems as per local legislation ( renewals, PSURs, label updates, CMC changes)Ability to manage/coordinate impact assessments for technical changes impacting marketing authorization, including working with various non-regulatory stakeholders, such as medical, marketing, manufacturing sites etc.Stay updated on local regulatory requirements, and guidelines, to ensure compliance with regulations and effectively communicate requirements to GRA and other team members as needed; participate actively in regulatory meetings, share insights and best practices within the organizationMaintain regulatory compliance and support HA inspections, as neededWorks effectively within a team environment but may work independently delivering services within their area of competenceWorks within broad project guidelines as directed by the project lead and/or technical SMEsTakes initiative to prioritize work to achieve specified project outcomes while confirming alignment with project lead and line managerCapitalizes on opportunities to improve one's own performance and seeks feedback from the project lead and colleaguesApplies information provided by the project lead or senior colleagues to complete assigned project activitiesProduces quality work that meets the expectations of project lead and the clientMay serve as a Project Lead for small scale projects or a Work Stream Lead on larger projects, and would be responsible for project planning and set-up and routinely interacts with the assigned Project Specialist (PS) or Project Manager (PM) to appropriately control the project (e.g. project set-up, forecasting and financial entries, invoicing, etc.)Functions as the main client contact and ensures accurate project reporting is in placeEnsures that the project team delivers to meet the client expectations for quality and timelinessEnsures that appropriate risk identification and issue-escalation procedures are in placeEnsures project specific training compliance of the project teamEnsures and/or manages project financials including provision of accurate revenue forecastsEnsures that the project team understand and work to the scope of the contractIdentifies new opportunities through Change In Scope or add-on business from existing workEnsures timely project close-out activities are completedConsulting Activities and Relationship ManagementFollows and implements the organization's consulting models and methodologies under the guidance of the project lead and/or Technical SMEDelivers consulting services within personal area of expertise under the guidance of the project lead and/or Technical SMECompletes assigned activities within project scope and objectives with an understanding of issues which may impact project profitability under the direction of the Project Lead and/or Technical SMEIdentifies project and internal issues to senior colleagues and Project Lead and/or technical SME and provides proposed solutionsInteracts professionally at all working levels within a client organization and within ParexelIdentifies project and/or client needs to the Project Lead and or Technical SME and collaborates with senior staff to define a proposed solutionInteractions result in clients expressing satisfaction with service providedMay assist in preparing and/or delivering a presentation with the support of senior colleaguesIdentifies and alerts PC management to opportunities for follow-on business or necessary changes in project scopeBusiness DevelopmentContinue to build a network of industry colleagues through relationships formed during project engagements or through other industry experienceCommunicates potential new business leads to PC management and account managersMay participate in project scoping calls and/or proposal preparation with the support of senior colleaguesParexel-Related ActivitiesMeets established metrics as specified in scorecard on an annual basisCompletes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, training compliance, project deliverable archiving, participation in internal initiatives/projects as requested by managementDefines self-development activities in order to keep current within the industry (i.e. maintain membership in a relevant industry and/or scientific/technical association)SkillsProject management knowledgeClient-focused approach to workResults orientationTeamwork and collaboration skillsExcellent interpersonal and intercultural communication skills, both written and verbalCritical thinking and problem-solving skillsProficiency in local language and extensive working knowledge of the English languageKnowledge And ExperienceMore than 3-5 + years of experience in an industry-related environment in Australia including Recent ZealandEducationMinimum of a Bachelor's Degree in a Scientific or Technical Discipline
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📌 Senior Regulatory Affairs Associate (Ra Generalist) - Fsp (Melbourne)
🏢 Parexel
📍 Melbourne