Senior Regulatory Affairs Executive

Posted 12 June 2022
SalaryNegotiable
LocationWaterford
Job type Permanent
DisciplineScience Careers
ReferenceBBBH532733_1655116705

Job description


Job Title: Senior Regulatory Affairs Executive
Location: Waterford
Summary:
Kelly Services and currently working with a pharmaceutical company based in the Waterford area. The Senior Regulatory Affairs Executive with report to the Director of Regulatory Affairs and will among other duties collate, prepare, and progress renewals, variations and marketing authorization application and provide regulatory support to the manufacturing function to ensure regulatory compliance of products manufactured on site.
Responsibilities:

  • 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 favorable 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 Director of Regulatory Affairs
  • Operational use of and input to the Pharmaceutical Quality System will be achieved by (a) maintaining the integrity of the Pharmaceutical Quality Systems and (b) by engaging with and utilizing the systems 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 systems performance
  • Actively contribute to and participate in continuous improvements to products, processes and the Pharmaceutical Quality System with the aim of minimizing patient, customer and business risks



Requirements:

  • Educated to at least degree level in a life science with significant experience in regulatory affairs
  • Membership of The Organisation for Professionals in Regulatory Affairs (TOPRA) is preferable
  • Ability to organize own workloads with a minimum of supervision
  • 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
  • Ability to leverage/ collaborate effectively with internal and external stakeholders
  • Excellent written and verbal communication and interpersonal skills
  • Strong problem-solver
  • Resourceful
  • Independent, critical thinker with strong decision-making skills
  • Comfortable working in a busy, fast paced, regulated healthcare environment
  • Solid experience/ ability in working well with others

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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.