NEW: EU MAA Labeling Optimization
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A global pharmaceutical company is seeking an experienced regulatory labelling expert to support the optimization of an EU label for an innovative product ahead of an EMA Marketing Authorisation Application (MAA).
The objective is to strengthen the presentation of clinical and functional outcome data within the submission and increase the likelihood of relevant data being reflected in the EU SmPC.
The Role
- Review and optimisation of relevant EU MAA documentation, particularly Module 2 sections.
- Literature review covering validation of a clinical assessment and relevant regulatory/label precedents.
- Assessment of clinical study results and how they can support the proposed labelling strategy.
- Evaluation of how a client-developed functional assessment can best be positioned within the submission.
- Consideration of previous scientific advice and other relevant supporting documentation.
- Approximately 2–3 virtual meetings, plus written recommendations/proposed submission language.
Requirements
Expert Profile Required:
Demonstrated experience in EU labelling optimisation for innovative products, including review and optimisation of documentation supporting an EMA MAA.
Deliverable:
Written proposals/recommendations for relevant submission documentation, supported by regulatory precedent and scientific evidence.
How to Apply
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