MSD Regulatory Affairs PA/Administrator 

Australia, New South Wales 

889041153

Job Description

Regulatory Affairs PA/Administrator

• Looking for a different challenge as a PA/Administrative Assistant?
• 12 months Fixed Term Contractwith competitive remuneration and benefits
• Location: AUS - New South Wales - Macquarie Park
• Hybrid, work from home and office environment, with a dedicated and welcoming team
• Join a growing, yet already successful market
• Upskill and growth in an area you’re passionate about , whilst being fully supported and encouraged
• Join a trusted Global leading Pharmaceutical organisation
• Graduates welcome to apply and be considered

Personal Assistance to RA (Regulatory Affairs) Director and General Administration

• Proactively support the RA Director with diary management
• Coordinate the submission of required Management reports
• Liaise with other Administrative Assistants, Regional colleagues and other departments
• Maintain departmental organisational chart
• Assist with onboarding for New Starters and attendance to company orientation
• Assist with the return of IT equipment & security card of exiting employees
• Provide administrative support for regulatory submissions including maintenance of resources and facilities
• Arrange equipment servicing and maintenance as required
• Ensure the working area is free of EHS hazards
• Prepare documents that require specialist input e.g. PowerPoint presentations and Excel spreadsheets
• Act as first point of contact for regulatory enquiries
• Triage the email messages from the Mailboxes, as required

General Financial administration

• Check all invoices and liaise with RA associates and/or managers to ensure accuracy for payment
• Review agreement Medicines Information, hotels and other suppliers, as required
• Perform monthly reconciliation of Corporate Purchase Card expenses
• Perform monthly reconciliation of RA Management team Corporate Purchase Card expenses
• Perform ad-hoc reconciliation of RA Management team and RA Director expenses
• Raise departmental Purchase Orders in accordance with applicable policies and SOPs
• Generate monthly report to reconcile with Finance and ensure accurate cross charging to various business units within our company

Meetings

• Organise RA team meetings and conferences
• Participate in discussions, prepare minutes and follow-through action points
• Book, set-up meeting rooms, and provide catering for meetings within budget

Specific Regulatory Projects

• Collaborate with the RA Managers to prepare TGA Annual Charge Exemption declaration
• Identify opportunities for system improvement within the RA Team and implement, following appropriate consultation and refinement
• Assist RA team in maintaining compliance with regulatory systems and processes
• Submit regulatory dossiers to Medsafe via EFT as requested
• Manage courier services for hard-copy submissions
• Responsibility for development and maintenance of “
  Documentation Support to Country Product Registration”
• Organise legalisation and notarization of regulatory documents
• Manage document retention (on-site and off-site) and manage external provider to scan regulatory documents

Travel 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 trainings

Education:

• Secretarial or administrative certification. Ideally, Bachelor’s Degree qualification in life sciences or other relevant field

Experience:

• 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 work
• Ability to manage conflicting priorities and respond in a timely, effective manner
• Cross-functional capability – ability to work effectively with and collaborate across functional partners
• Effective communication and interpersonal skills
• Drive results – skill in driving efficiency that removes obstacles to accomplishing goals
• Empowerment/delegation – ability to make decisions, clarify expectations, and hold others accountable through the organization by appropriately sharing responsibilities with others
• Customer focus & relationship management – ability to partner with internal and external stakeholders in delivering value by understanding and meeting their needs and/or expectation
• Creative problem solving – ability to bring break-through thinking to create solutions that deliver exceptional results
• Strong computer skills (Words, Excel, Power-Point). Experience in Power BI will be greatly appreciated

What You Can Expect

• Work autonomously whilst being supported, encouraged and being part of a trusted Global leading Pharmaceutical organisation
• Exposure to upskill and develop in your role
• Flexibility and opening doors to other opportunities and skillsets
• Joining acollaborativeteam oflikeminded individuals

Current Contingent Workers apply

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