Description
My client, a global provider of outsourced development services to the multiple industries, is currently recruiting a Regulatory Manager to be based in Dublin. As Regulatory Manager, the successful candidate will work in Global Regulatory Affairs and form part of the EU and Asia-Pacific Regulatory team, a successful and driven team that provides consultancy for all my clients' projects globally as well as stand-alone contracts. The successful candidate will also manage Regulatory Affairs activities on regulatory projects and clinical trials undertaken by my client.Responsibilities:
- Expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
- Apply scientific principles and maximize compliance to all aspects of regulatory activities undertaken.
- Prepare and /or support proposals and bids.
- Effectively manage all the aspects of allocated projects in 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.
- 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.
- Seek to improve and optimize information/communications within RA on emerging regulations.
- Help the RA group to develop strategies to build capabilities to use emerging legislation to my clients' competitive advantage.
Experience and Qualification:
- Significant regulatory affairs experience including major experience in Pharmaceutical/CRO experience.
- Demonstrable experience within regulatory affairs, including document preparation and/or writing, clinical trials, post-licensing activities and regulatory agency interaction
- Strong organizational skills, ability to manage multiple tasks and meticulous attention to detail.
- Bachelor's degree, or local equivalent, in the sciences, or equivalent experience qualification. Masters' degree or higher in the sciences, preferred.
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.