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Regulatory Affairs Administrator

Penicuik, Mid LothianPermanent
Experience Dependant
Job Reference: J5631926
Updated On: 23/07/2019
Status: Now Interviewing
Hyper Recruitment Solutions
Sectors: Pharmaceutical, Biotechnology, Medical Device, Contract Research Organisation, Contract Manufacturing Organisation, Contract Testing Organisation, Chemicals, Nutraceutical, Life Sciences, Cell & Gene Therapy, Bioprocessing, Animal Health, Science

Skills: Regulatory Affairs - UK, Regulatory Affairs - Animal Health, Misc - Person Assistant / Executive Assistant, Misc - Administration Offier / Assistant, Misc - Admin Manager, Regulatory Affairs - Administrator, Misc - Medical Communications

Job Information

Role Overview

We are currently looking for a Regulatory Affairs Administrator to join a growing animal health company based in the Mid Lothian area.

As the Regulatory Affairs Administrator you will provide professional administration support to the members of the regulatory affairs team and wider R&D group. You'll be involved in the day to day running of a fast moving regulatory department, and play an integral role within the team. You'll be involved in the preparation of regulatory documentation, administration of filing and archiving, maintenance of regulatory submission portals and the regulatory submission calendar.

Key Duties and Responsibilities

Your duties as the Regulatory Affairs Administrator will be varied however the key duties and responsibilities are as follows:

1. Working with regulatory affairs team to prepare dossiers and submission documentation for the registration of veterinary medicinal products globally (preparation of PDF documentation). This will include proof reading of scientific documents

2. Assist in life cycle management of registered products, maintaining the submission and approval calendar.

3. Assists the regulatory team in the maintenance and archiving of regulatory documentation and in the maintenance of regulatory systems.

4. Maintains the electonic submission portals for the EU and USA.

5. Maintains licences and subscriptions for regulatory systems.

6. Processes financial purchase orders and invoices for R&D through SAP

Role Requirements

To be successful in your application to this exciting opportunity as the Regulatory Affairs Administrator we are looking to identify the following on your profile and past history:

1. Previous experience in providing administrative support to a department is essential. Previous experience in working in a regulated industry such as pharmaceuticals or clinical trials and experience in handling scientific documentation would be preferred. Exposure to SAP Business ByDesign would be useful.

2. We are looking for a candidate who can offer flexibility and can work effectively in a fast paced, rapidly changing environment, working on multiple projects simultaneously.

3. Excellent verbal, written and presentation communication skills with experience in project reporting.

Key Words: Administrator | Regulatory Affairs | Documentation | Pharmaceutical | Clinical | Animal Health
Eve Hegarty
Your Recruitment ConsultantEve Hegartyeve.hegarty@hyperec.com
DisclaimerHyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.