ParexelSenior Regulatory Affairs Associate
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