JOB SPECIFICATION

Job Title: Regulatory Administrator

Reporting to: Head of Regulatory Affairs

ROLE

• To provide administrative support to the Regulatory Department.

DUTIES

• To assist Head of Regulatory/ Regulatory Execs in maintenance of all admin aspects of Regulatory Department. To help with the establishment of electronic and hard copy filing systems.

• To assist Regulatory Executive and Regulatory Manager with the establishment and population of a Regulatory database containing key details of all product authorizations.

• Responsibility for tracking and updates to Applications Database

• Responsibility for incoming/outgoing correspondence database

• To assist with the co-ordination of key regulatory documents/dossiers incoming from Global Regulatory.

• To prepare forms & dossiers for the Irish Medicines Board.

• Responsibility for collating Parallel Product Authorisation &Generic Product information & dissemination of same

• To assist with Transfer of Product Authorisation both to & from the UK.

• To assist with the review of artwork

• To maintain and update electronic, hard copy and archive filing systems.

• To organise in-house meetings

• To take messages and action as appropriate in the absence of colleagues.

JOB EXPERIENCE

Essential Experience

• Experience in a similar role working for a major multinational. Ideally with regulatory experience.

• Has operated in a busy environment.

• Has operated in a team environment.

• Has a working knowledge of MS Word, Excel. Also Powerpoint (desirable).

EDUCATION

Leaving Certificate or equivalent

COMPETENCIES

• Aware of others needs within the team

• Attention to detail.

• Version control.

• Energetic and committed.

• Must have excellent communication skills.

• Planning & organising

• Approachability

• Customer Focus

• Initiative

• Takes direction