Senior Regulatory Affairs Executive

  • Sandoz (Novartis)
  • Oct 04, 2019
Full time Research Science

5 Jobs

Job Description:

Your Responsibilities

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

Minimum requirements

  • 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

Desirable Requirements

  • 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

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