Regulatory Affairs Advisor

Regulatory Affairs Advisor

Job Description

• Ownership/regulatory responsibility for a portfolio of products and be responsible for close liaison with the management/other key personnel in the definition of product strategies in line with timeframes for approval.
• Medical writing, review of SPC, labelling and management of local prescribing information during product lifecycle.
• Propose and implement 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 and influence.
• Provision of guidance/technical support in the preparation of dossiers applications/submissions
• Responsibility, ownership and execution of internal audits, creating reports and feedback on findings.
• Support other team members with the implementation of the quality management systems and objectives to achieve ISO 9001

Position Requirements

• B.Sc. Minimum or pharmacy primary degree.
• 3 years+ experience of human medicinal product Regulatory Affairs in the Pharmaceutical Industry. Experience in the Medical Device Sector for EU markets an advantage.
• Experience with NeeS/eCTD submissions
• Strong commercial awareness and an innate ability to assess the commercial implications of decisions and advice.
• Experience in the preparation and submission of new applications, variations and renewals for multiple EU markets.
• Experience in the management of DCP's, Centralised or other European procedures
• 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.
• Excellent attention to detail and solid interpersonal, communication and organisational skills required.
• Be an authority on the Irish and European Regulatory Framework.
• Motivated self-starter with ability and desire to progress.

To apply please contact Gemma Reid at Morgan McKinley at 051 309650 or email your CV confidentially to greid@morganmckinley.ie