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Regulatory Affairs Administrator

Introduction


Our client is a global animal health company dedicated to supporting customers and their businesses in ever better ways. Building on 60 years of experience, they deliver quality medicines and vaccines and supported by a range of services. Their mission is to better understand and address the real-world challenges faced by those who raise and care for animals.


Function information


You will:

facilitate the approval and maintenance of new and in-line veterinary products by providing administrative support to all Veterinary Medicine Regulatory Affairs (VMRD) teams. In this role, you will provide day to day support to the administration team by providing tactical direction, including prioritization of activities and deliverables consistent with the business goals. You will be a point of contact in the administration team for interacting with both external (eg. regulatory agencies) and internal (eg: regulatory directors) personnel to proactively manage issues and contribute to the effective delivery of business goals and the smooth running of the VMRA department.

Your Responsibilities:

  • You will contribute to the day to day activities and priorities of the VMRA administration team, including oversight and prioritization of administrative tasks.
  • You will contribute to management discussions on future trends, problem solving and prioritization in the context of achieving the departmental goals and implementing continuous improvement activities.
  • Your will represent VMRA on design and implementation of business programs in order to optimize business processes.
  • Your role will include being a point person for external regulatory agencies in order to facilitate effective business processes, (eg. payments and submission of regulatory application dossiers to the European Medicines Agency [EMA] as well as the national medicines agencies).
  • Your role will include a multiple administration support the effective operation of the department by taking responsibility for the execution of key activities such as: meeting organisation (internal and external), visitor arrangements, travel booking, distribution of incoming mail, dispatch of outgoing mail and courier packages, including preparation of cover letters, requests for IT and HR support, e.g. for New Starters, maintenance of contact and responsibilities lists, translation, notarisation and legalisation of documents, ordering of office supplies and submission of maintenance requests, compilation and/or copying of small regulatory dossiers, conversion of files to pdf format and document management and status reports associated with acquisitions and divestments.



Requirements


An appropriate education in administration with a minimum of 5-7 years previous experience as an administer using formal administration methodologies. The successful candidate will have experience working in a dynamic multicultural environment and working with colleagues based in multiple countries.

Technical Skills Requirements

At a minimum:

  • Detailed understanding of effective administrative support to a colleagues / teams in a multicultural, dynamic and constantly changing learning environment.
  • High level of competency using Microsoft Office suite – with demonstrated high level competence of working in Microsoft Word and Excel.
  • Must be able to effectively communicate in English with colleagues at all levels of the organization and external regulatory agencies.
  • Consistently model behaviors of accountability and ownership through approachability, excellent interpersonal, communication, negotiation and problem solving skills.
  • Ability to work independently, while fostering good working relationships across physical distance and have flexibility and the capacity to handle multiple tasks at once.
  • Attention to detail is critical to ensure that the expectations of all regulatory submissions to medicines agencies are met.
  • Able to demonstrate evidence of being a highly effective team player, be a problem solver with an ability to take ownership for issues with the ability to come up with creative solutions and implement them successfully.
  • He/she will be able to influence without authority, support colleagues outside of VMRA as the need arises.


Desirable:

  • Experience using all programmes in the Microsoft Office suite.
  • Experience with financial management, including budget forecasting and management.
  • An effective communicator that has at least one additional European language.
  •  Working knowledge of drug and vaccine development process is an asset.

Offer


A permanent contract and a rewarding career through the provision of a challenging role in a multicultural environment that supports continuous learning and development. The successful candidate will have ownership for key team objectives and be an integral part of a successful team that delivers novel medicinal products to treat and prevent diseases in animals.



Information


Not ready to apply or you still have questions?

Please give me a call on +32 10 80 71 03, I’ll be happy to give you more information!

Ready for this new challenge?!

Please send me your CV and your cover letter in a WORD format:

Carine Steurs

Recruitment eXPErt

carine.steurs@xpe-group.net


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