Description
My client, a global provider of outsourced development services to the multiple industries, is currently recruiting a Regulatory Specialist to be based in Dublin. As Regulatory Specialist, the successful candidate will work on the Global Regulatory Affairs team. This is a successful and driven team that provides consultancy for all my clients' projects globally as well as stand-alone contracts. Duties will vary depending on the nature of the projects to be undertaken but will mainly fall within the areas of Pharmaceutical, Biotechnology or Biologics Regulatory Affairs.Responsibilities:
- Effectively contribute to all the aspects of allocated projects in a timely manner including tracking (time and resources), proactive identification of risks, scope change, financial implications and provision of solutions for approval by Directors.
- Participate in regulatory and/or clinical trials project teams as required.
- Initiate research and regulatory intelligence in support of designated regulatory activities as required, and provide information on regulatory requirements.
- Prepare, compile and submit CT/IND, MAA/NDA, Variations/Lifecycle submissions, DSUR, PSUR, Renewals, Agency briefing documentation
- Manage and implement label reviews, translation requirements and fee requirements for regulatory submissions.
- Input to regulatory Intelligence function.
- Readability testing.
- IMPD/IB Core Doc review, labelling review for CT.
- May work either as a part of the Regulatory Submissions team or as part of a regulatory or cross functional team depending on the size and nature of project.
Experience and Qualification:
- Bachelor's degree, or local equivalent, in the sciences, or equivalent experience qualification - Prior relevant experience in regulatory affairs or aligned work in Pharmaceutical/ Pharmaceutical contract service industry.
- Strong organizational skills, ability to manage multiple tasks and meticulous attention to detail.
If you are interested in this position please apply directly or contact me Adele Moran on for immediate consideration. Sthree UK is acting as an Employment Agency in relation to this vacancy.