Regulatory Affairs Admin Assistant

On behalf of our client, a global pharmaceutical company, we are recruiting for a Regulatory Affairs Assistant. This is a permanent, full-time role.

The Regulatory Affairs Assistant will assist with various administrative tasks relating to RA Dept. The Regulatory Affairs Assistant will maintain a positive attitude that promotes teamwork within the company and a favourable image of the company. General activities are listed below but are not restricted to those, other duties may be assigned by RA Manager / Head RA

Responsibilities

GENERAL ADMINISTRATIVE ACTIVITIES

• General clerical duties including photocopying, fax and mailing, distribution of incoming correspondence
• Maintaining in-/out-coming correspondence register
• Enter and maintain data in electronic systems; ensure electronic information is complete & accurate
• Maintain hard copy filing systems in accordance with established company internal standards
• CPP requests via interactions with Health Authorities
• Arrange for payment of honorariums for external parties, such as notary, experts, translators, etc.

RA SUPPORT ACTIVITIES

• Schedule and coordinate meetings, appointments and travel arrangements for RA department staff
• Assist with administrative activities related to dossier preparation and compilation for new submissions, variations, and other regulatory filings
• Assist with dispatch of regulatory packages to global RA affiliates or to Health Authorities
• Management of incoming IP and local dossiers from intake to archive and including scanning
• Maintenance of RA databases / filling systems / group inboxes

BUDGET-RELATED ACTIVITIES

• Arrange for payment of honorariums for external parties, such as notary, experts, translators, etc.
• Preparation of expense reports that may involve exchange rate calculations
• Reconciliation of department charges and expenses
• Maintain office supply inventories

CUSTOMER SERVICE

• Maintain a professional, confident and reliable manner when dealing with enquiries
• Ensure that requests are properly understood and recorded accurately; request clarification if necessary
• If any delays in responding to queries are experienced or expected, inform the party/s concerned about the reason for the delay and continuously follow up until the request has been satisfied

PERSONAL DEVELOPMENT

• Identify learning and development needs on an on-going basis
• Propose development solutions as appropriate

Qualification, Experience and Requirements

• Minimum 1 years’ experience in an administration support role
• Computer literate – Advanced MS Office essential
• Knowledge of  IT tools generally utilised in RA / QA departments an advantage
• Insight and experience within Pharmaceutical industry an advantage
• Knowledge of EU current requirements about administrative part of registration dossier an advantage but not essential
• Knowledge of other administrative requirements in international countries of registration an advantage but not essential

For more information and to apply for this role please call Zoe on +353 1 2784671 or e-mail zhamilton@thornshaw.com

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671