Job Description
Job Description Summary
At Sandoz, our Purpose is pioneering access for patients
Job Description
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:
At Sandoz, our Purpose is pioneering access for patients
Job Description
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:
- 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...