Job Description
Regulatory Affairs PA/Administrator Looking for a different challenge as a PA/Administrative Assistant?12 months Fixed Term Contract with competitive remuneration and benefitsLocation: AUS - New South Wales - Macquarie ParkHybrid, work from home and office environment, with a dedicated and welcoming teamJoin a growing, yet already successful marketUpskill and growth in an area you're passionate about, whilst being fully supported and encouragedJoin a trusted Global leading Pharmaceutical organisationGraduates welcome to apply and be consideredThe primary responsibility of the Regulatory Affairs Administrator is to provide personal assistance and administrative support to the Regulatory Affairs (RA) Director and Team. This support includes general administrative activities, management of key regulatory documents, and specific regulatory projects as needed.
Of critical importance to the successful execution of this role are peer relationships, action oriented, integrity & trust, customer focus, time management, learning on the fly, organising & composure.
What You Will Do Responsibilities include, however not limited to: Personal Assistance to RA (Regulatory Affairs) Director and General Administration Proactively support the RA Director with diary managementCoordinate the submission of required Management reportsLiaise with other Administrative Assistants, Regional colleagues and other departmentsMaintain departmental organisational chartAssist with onboarding for New Starters and attendance to company orientationAssist with the return of IT equipment & security card of exiting employeesProvide administrative support for regulatory submissions including maintenance of resources and facilitiesArrange equipment servicing and maintenance as requiredEnsure the working area is free of EHS hazardsPrepare documents that require specialist input e.g. PowerPoint presentations and Excel spreadsheetsAct as first point of contact for regulatory enquiriesTriage the email messages from the Mailboxes, as requiredGeneral Financial administration Check all invoices and liaise with RA associates and/or managers to ensure accuracy for paymentReview agreement Medicines Information, hotels and other suppliers, as requiredPerform monthly reconciliation of Corporate Purchase Card expensesPerform monthly reconciliation of RA Management team Corporate Purchase Card expensesPerform ad-hoc reconciliation of RA Management team and RA Director expensesRaise departmental Purchase Orders in accordance with applicable policies and SOPsGenerate monthly report to reconcile with Finance and ensure accurate cross charging to various business units within our companyMeetings Organise RA team meetings and conferencesParticipate in discussions, prepare minutes and follow-through action pointsBook, set-up meeting rooms, and provide catering for meetings within budgetSpecific Regulatory Projects Collaborate with the RA Managers to prepare TGA Annual Charge Exemption declarationIdentify opportunities for system improvement within the RA Team and implement, following appropriate consultation and refinementAssist RA team in maintaining compliance with regulatory systems and processesSubmit regulatory dossiers to Medsafe via EFT as requestedManage courier services for hard-copy submissionsResponsibility for development and maintenance of "Documentation Support to Country Product Registration"Organise legalisation and notarization of regulatory documentsManage document retention (on-site and off-site) and manage external provider to scan regulatory documentsTravel Coordination and Support Assist in arranging international and domestic travel including accommodation for the RA Team in accordance with our company's SOPs and guidelines, and budget.Personal and Professional Development Attend internal and external trainings to develop and maintain a broad and current knowledge of regulatory affairs, and relevant areas of administration.Agree with manager and implement a relevant and achievable Development Plan to ensure ongoing development of personal and professional skills.Keep up to date with current systems by attending classroom and online trainingsWhat You Must have Education: Secretarial or administrative certification. Ideally, Bachelor's Degree qualification in life sciences or other relevant fieldExperience: Administrative role preferably in life sciences.Strong document management experience (hard and e-copy)Critical Competencies: Superior organisational skills, attention to details and systematic approach to workAbility to manage conflicting priorities and respond in a timely, effective mannerCross-functional capability – ability to work effectively with and collaborate across functional partnersEffective communication and interpersonal skillsDrive results – skill in driving efficiency that removes obstacles to accomplishing goalsEmpowerment/delegation – ability to make decisions, clarify expectations, and hold others accountable through the organization by appropriately sharing responsibilities with othersCustomer focus & relationship management – ability to partner with internal and external stakeholders in delivering value by understanding and meeting their needs and/or expectationCreative problem solving – ability to bring break-through thinking to create solutions that deliver exceptional resultsStrong computer skills (Words, Excel, Power-Point). Experience in Power BI will be greatly appreciatedWhat You Can Expect Work autonomously whilst being supported, encouraged and being part of a trusted Global leading Pharmaceutical organisationExposure to upskill and develop in your roleFlexibility and opening doors to other opportunities and skillsetsJoining a collaborative team of likeminded individualsWe are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Employee Status: Temporary (Fixed Term)
Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid
Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 12/30/2024
*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R322830
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