Senior Regulatory Affairs Executive

Excellent new role for a Senior Regulatory Affairs Executive in a growing pharmaceutical company based in Waterford City. Reporting to the Head of Regulatory Affairs, The purpose of this role is to
  • Collate, prepare and progress renewals, variations and marketing authorisation applications
  • Supervise the administration of the eMC website and ensure EVMPD compliance
You will be responsible for
  • Advising on regulatory requirements for assigned projects;
  • Collation and submission of documentation for variations, renewals and marketing authorisation applications;
  • Monitoring the above to grant;
  • GMP documentation review and sign off;
  • Supervising the administration of the eMC website and ensuring EVMPD compliance;
  • The job-holder will, under the guidance and support of the Head of Regulatory Affairs, actively contribute to the routine operational use of and input to the site Pharmaceutical Quality System by complying with defined procedures and policies.
The job will include the following
  • 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 Head 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 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.
  • 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.
The ideal candidate will
  • 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;
  • 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.