Regulatory Affairs Consultant

Regulatory Affairs Consultant
Responsibilities:
Ownership/ regulatory responsibility for a portfolio of products for nominated clients and responsibility for close liaison with the Management / other key personnel of the relevant business unit in the definition of product strategies in line with timeframes for approval.
Proposes and implements effective strategies to minimise the timing of and optimise the commercial viability of product licenses.
Responsibility for the preparation of Package Leaflet User-Test or Bridging Reports.
Builds and maintains strong relationships with EU Competent Authority to ensure ease of access andinfluence.
Provision of guidance/technical support in the preparation of EU CTD dossiers applications including eCTD & NeeS submissions
Support other team members with the implementation of the QMS and objectives to achieve ISO 9001

Requirements:

• B.Sc. Minimum or pharmacy primary degree.


• Greater than 3 years experience of pharmaceutical regulatory affairs


• Strong commercial awareness and an innate ability to assess the commercial implications of Rounded knowledge of the national and EU regulatory framework.


• Ability to project manage across a diverse and complex portfolio of products and priorities.


• Ability to get on with people, to influence people both internally and externally and to achieve objectives.

If you would like further Information you can contact the recruiter directly:

Brian Christensen | Tel: +353 (0) 1 685 4747