Regulatory Affairs Executive - Dublin West
Purpose
To effectively manage allocated projects to obtain optimal Regulatory Authority approvals thereby supporting the business functions.
To support the international drug development process by active involvement in the global regulatory function.
Key Tasks
· Responsible for the preparation and distribution of approved abridged prescribing information to marketing executives and product managers.
· Responsible for the information flow from Global Regulatory Group to marketing colleagues ensuring that the marketing department are fully up to date with the regulatory status of their products.
· Local responsibility for product recalls due to quality defects/non compliance.
· Responsible for IMB approvals for clinical trials.
· To develop and maintain a close working relationship with key individuals at the IMB.
· Close collaboration with the regulatory functional group based at Welwyn, UK to enable effective management of the Irish portfolio of licences.
· Effective collaboration with other affiliates and functions to (i) help achieve business targets and (ii) anticipate and address potential regulatory issues.
· To effectively utilise and communicate relevant world-wide regulatory experiences and intelligence thereby providing a competitive edge.
Skills Profile
· BSc (life sciences/health sciences degree) OR clear demonstration of scientific knowledge/aptitude
· A minimum of 2 years experience in a regulated GXP environment.
· Basic working knowledge of drug discovery, development, manufacturing and marketing.
· Excellent Communication Skills
· Excellent Organisational Skills
Call Storm REcruitment on 2557377 or email your cv today
