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Regulatory Affairs Executive

Company

Sandoz UK & Ireland

Location

bracknell, United-Kingdom

Type

Full-time

The performance of various regulatory activities to ensure timely, accurate and strategic preparation and submission of registration dossiers to obtain and launch new UK Marketing Authorisations whilst also supporting business needs such as re‑introductions and portfolio expansion projects.

Your Key Responsibilities

Your responsibilities include, but not limited to:

  • The execution of business aligned regulatory filing strategies in collaboration with regional and local stakeholders to meet the product launch deadline.
  • Preparation and submission of the following New Marketing authorisation application (National/DCP/MRP/CP), MA variation, Change of ownership applications and educational materials and associated risk minimisation measures.
  • Timely execution of launch enabling regulatory activities such as the registration of Risk Management Plans and associated educational materials, the registration and sign off artworks, approval o...

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