Regulatory Affairs PA/Administrator

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 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
  
  

The 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 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
  
  

What You Must Have

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 a collaborative team of likeminded individuals
  
  

We 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.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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 BEFORE the 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