Ref. no.: JO-1112-239904
Tags: regulator affairs advisor regulatory affairs officer dublin Regulatory regulatoryaffairs regulatory affairs officer regulatory affairs specialist
Location(s): Dublin North Dublin South Leinster
Salary range (€): Negotiable
Additional benefits:
Minimum experience required: 3 - 4 Years
Employment type: Permanent Full-time
Minimum qualification: See Description
Contact person: Linda Dunne
Contact e-mail: ldunne@thornshaw.com
Job description: A new role for a Regulatory Affairs Officer based in Dublin. This is a full time permanent position and is a field based role. A fantastic opportunity to develop your skills in a consultancy role. We are looking for someone with 2-3 years experience and a self starter. PURPOSE / KEY RESPONSIBILITIES: Ownership/ regulatory responsibility for a portfolio of products for nominated client and be responsible 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 and influence. 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 Qualifications/Minimum Required: (Education/Experience/Competencies)B.Sc. Minimum or pharmacy primary degree. Greater than 3 years experience of human medicinal product Regulatory Affairs in the Pharmaceutical Industry. Strong commercial awareness and an innate ability to assess the commercial implications of decisions and advice. Rounded knowledge of the national and EU regulatory framework.Excellent written and oral communication skills. 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. Above average attention to detail and solid interpersonal, communication and organisational skills required. Ability to work independently with minimal supervision. Motivated self-starter. Ability and desire to progress.
For further information please call Linda at 01 2784671 or email your CV in the strictest confidence to ldunne@thornshaw.com . Log on to www.thornshaw.com for more jobs.
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