Senior Regulatory Affairs Associate
- Submitting labelling / safety variations in EU countries including UK and Ireland
- Preparation and review of M1 documents – Cover letter, eAF , Mock-ups, Clinical Overview, Literature References
- Handled MRP and National procedures in EU
- Updating the labelling impacted documents - SmPC, PIL and/or Label
- Artwork update coordination
- Veeva experience with tracking submissions, updating status, creating HAQ’s
- Excellent communication and CFT coordination.
- HA correspondence and checking agency websites for approved information
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