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The Senior Regulatory Affairs Associate is responsible for submitting labelling and safety variations in EU countries, including the UK and Ireland. This involves the preparation and review of M1 documents such as Cover Letters, eAFs, Mock-ups, and Clinical Overviews, alongside updating impacted labelling documents.
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
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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