Regulatory Affairs Assistant/Administrator-PHARMA

Role Description

Our client, a global pharmaceutical company, are currently recruiting for a Regulatory Affairs Assistant. This is a contract role, duration to be confirmed.

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 team work within the company and a favourable image of the company.

RA AND ADMINISTRATIVE SUPPORT
1. Support to Regulatory Teams
• Assist and provide support to the regulatory compliance, submissions & Group teams
• Compliance tracker
• Logging & tracking requests for the compliance team
• Supporting requests for admin documents
• Generating reports
• Weekly update to group
• Keeping compliance inbox up to date
• Workload tracker
• Weekly update of spreadsheet
• Generating reports
• Certificates of Pharmaceutical Product – eg Irish, UK & Dutch
• Applying to Health Authorities for CPP’s to support submissions globally
• Maintaining and Issuing weekly CPP tracker updates.
• Notary/Apostille/Legalisation
• Liaising with solicitors, Department of Foreign Affairs & Embassies
• Process documents for EU and global teams
• Supporting EU and global teams variations/submissions with administrative documents.
2. Compilation of registration fillings for identified countries
3. Maintenance of RA databases/filling systems
• Implement and regular up-date of the Registration Fees database for identified territory.
• Enter and maintain data in RA electronic systems; ensure electronic information is complete and complies with established company's standards.
• Maintain hard copy RA filing systems in accordance with established company internal standards.
4. Administrative and budget related tasks
• Research and assist with the preparation of procedure related to RA area.
• General clerical duties including photocopying, fax and mailing (incl. distribution of incoming correspondence).
• Maintaining in-/out-coming correspondence register.
• Guide and instruct new or less experienced staff regarding technical or administrative problems.
• Schedule and coordinate meetings, appointments and travel arrangements for RA department staff.
• Checking the monthly leaves reports provided by Office Manager

Requirements

• Minimum 1 years’ experience in a similar office based position
• Insight and experience within Pharmaceutical industry an advantage
• Computer literate – MS Office
• Knowledge of EU current requirements about administrative part of registration dossier
• Knowledge of specific national administrative requirements in usual target countries of registration
• Exceptional organisational skills
• Excellent Interpersonal and communication skills
• Sense of urgency – responding to issues and opportunities in a timely manner
• Take ownership and accountability for activities. Positive and pro-active approach to business tasks
• Ability to lead and support several concurrent projects/products and develop strong relationship within cross-functional teams.
• Positive ‘can – do’ attitude. Be able to work autonomously and have good problem solving skills. Highly driven with enthusiasm to meet role requirements and to cope under demanding pressure
• Ability to prioritise decisions and activities to ensure efficient use of resources and address critical issues impacting the business
• Detail oriented, ability to multi-task and work with a high degree of accuracy
• A solutions provider with strong multi-tasking abilities
• Manage evolving deadlines effectively with regular feedback and updates.

If you are interested in applying for this role please call Linda on +353 1 2784671 or email ldunne@thornshaw.com
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com

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