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Senior Regulatory Affairs Specialist

Ref: 9222725

  • €50,000 - €60,000
  • 26 Apr 2021
  • Tipperary
  • Perm

A leading Pharmaceutical Manufacturer in Tipperary is seeking to hire a Senior Regulatory Affairs Specialist.

About the Job:

  • Comply with SOPs and assist in their development and review.
  • Operate and propose improvements to internal systems.
  • Assist in the development of regulatory strategies.
  • Determine and communicate submission and approval requirements.
  • Assess the acceptability of documentation for submission
  • Coordinate and prepare submission packages for regulatory agencies. Monitor the content of the dossiers ensuring the content is consistent, understandable and the results clearly expressed and that open questions have been dealt with
  • Respond to questions raised by regulatory authorities by obtaining the relevant information from departments concerned
  • Negotiate with regulatory authorities to achieve most favourable conditions for marketing authorisations or variations
  • Commission and approve artwork for compliance prior to final signoff
  • Draft Summary of Product Characteristics, Patient Information Leaflets and packaging
  • Monitoring legislation and professional publications to maintain awareness of current regulatory practice and provide information on regulatory requirements to other departments and/or business units
  • Respond to external/internal regulatory information requests
  • Review GMP documentation for regulatory compliance, as directed
  • Represent regulatory affairs at internal and external meetings as directed by the Regulatory Affairs Manager
  • Operational use of and input to the Pharmaceutical Quality System will be achieved by maintaining the integrity of the Pharmaceutical Quality Systems, by engaging with and utilising the system in accordance with defined procedures and policies. The job holder will, through supervisory guidance, contribute to improving the effectiveness of the Pharmaceutical Quality Systems by collection of metric data and other essential associated information which measures the system performance. In addition they will actively contribute to and participate in continuous improvements to products, processes and the Pharmaceutical Quality System with the aim of minimising patient, customer and business risks
  • About You:

  • Educated to at least degree level in a life science with significant experience in regulatory affairs.
  • Membership of The Organization for Professionals in Regulatory Affairs (TOPRA) is preferable.
  • Ability to organise own workload with a minimum of supervision.
  • He/she should have a basic appreciation of all aspects of the working of the pharmaceutical industry.
  • Experience with information technology desirable.
  • Exceptional eye for detail required.
  • Requires the ability to present the Company’s interests in a professional and authoritative manner and to conduct negotiations with regulatory bodies.
  • For more on the role call Nigel on 087 3618142 or send your CV for consideration.