Senior Regulatory Affairs Associate (Marketing Application)

<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><b>The Senior Associate will p</b>rovide an overview of the responsibilities of the position by providing a summary of the most important aspects and duties of the position.</p><ul><li>Lead Local Regulatory Responsible (LRR) oversees LRRs to ensure effective deicion making and mooth operations and acts as the first escalation point for LRR challenges.</li><li>Local Regulatory Responsible focuses on local regulatory requirements and Health Authority national engagements.</li><li>The key interactions are with local external stakeholders e.g. Health Authorities, Local industry association(s), In Market commercial counterpart and Regional Regulatory Lead (RRL) counterparts in respective GRA Regional team</li></ul><p></p><p><span><b>Experience:</b></span></p><ul><li>5&#43; years of (local) regulatory knowledge and experience in a regulatory authority facing role; i.e. comprehensive understanding of regional and global regulatory requirements, guidelines and processes</li><li><span>Leadership experience</span></li><li><span>In-depth expertise on local health authority management</span></li><li><span>Project management skills and leadership skills; i.e. proven experience in managing e.g., regulatory submissions, timelines and cross-functional teams to ensure timely and successful product registrations and compliance</span></li><li><span>Experience in managing ComOps Stakeholders: matching influencing style to stakeholders to maximise impact and effectiveness of GRA expertise, proactively identifying opportunities to influence stakeholders on business critical decisions and employing a systematic approach to influence key internal stakeholders based on business needs and objectives</span></li><li><span>Experience in successfully dealing with rapid change</span></li></ul><p><br /><span><b>Competence:</b></span></p><ul><li>Fluent in local language and English, oral and written</li><li>Relevant bachelor’s degree or equivalent secondary education e.g. natural sciences (biology, chemistry with pharmacological focus)</li><li><span>Expert MS Office skills</span></li><li><span>Excellent organizational, time management and interpersonal skills in a global environment.</span></li><li><span>Ability to work successfully in a complex global matrix organization.</span></li><li><span>Proven ability to work effectively both independently and in a team.</span></li><li><span>The expertise, determination and courage to resolve or escalate issues as appropriate.</span></li></ul>