Your responsibilities include, but are not limited to
- To be a proactive and trusted member of the DRA team driving effective cross-functional working to achieve company objectives and ensure compliance.
- Support RA Manager and National RA Manager when required, including training team members and providing regulatory support for inspections and audits.
- Effectively collaborate with QA regarding Quality Management System (QMS) updates.
- Collation and reporting of KPI metrics.
- Working in accordance with Global and local Working Instructions and SOPs, implementing efficiencies where appropriate.
- To have a high awareness of the educational material registration process, working cross-functionally to ensure all commitments are met and implementation is appropriately recorded.
- To demonstrate attention to detail and business awareness when preparing and submitting the following
- MA variation, renewal and Article 61.3 applications
- Change of ownership applications
- MRP/DCP National Phases
- Licence cancellations
- Sunset clause
- Creation, assessment and approval of artwork texts, mock-ups and SmPCs Accurate maintenance of regulatory archives.
- The processing and clear communication of regulatory approvals to internal and external stakeholders.
- Provision of regulatory support for strategic commercial opportunities with effective cross-functional collaboration during product launch preparation.
What You’ll Bring To The Role
- BSc in Life Sciences
- Experience performing medicinal product regulatory activities (lifecycle maintenance/new MA applications)
- Demonstrated ability to drive regulatory activities in order to meet Health Authority deadlines and business needs
- Ability to effectively communicate with internal and external stakeholders a work cross-functionally Comfortable working in a fast-paced environment, adapting and changing priorities when required
- Experience working with CMC elements of a product dossier
- Experience of project management
- Experience of providing regulatory support for inspections and audits
- Experience of providing effective training