Senior Regulatory Affairs Associate

<p><b>When our values align, there&#39;s no limit to what we can achieve.</b><br /> <br />At Parexel, we all share the same goal - to improve the world&#39;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.</p><p>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&#39;re committed to making a difference.</p><p></p><p></p><p>Senior Regulatory Affairs Associate</p><ul><li>Submitting labelling / safety variations in EU countries including UK and Ireland</li><li>Preparation and review of M1 documents – Cover letter, eAF , Mock-ups, Clinical Overview, Literature References</li><li>Handled MRP and National procedures in EU</li><li>Updating the labelling impacted documents - SmPC, PIL and/or Label</li><li>Artwork update coordination</li><li>Veeva experience with tracking submissions, updating status, creating HAQ’s</li><li>Excellent communication and CFT coordination.</li><li>HA correspondence and checking agency websites for approved information</li></ul>