Senior Regulatory Affairs Consultant

<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>Main Responsibilities and Accountabilities of RPR: </b></p><ul><li><p>Strategy (execution) &amp; (partner) management</p></li></ul><p>- Ensure oversight on key processes and ensure framework is in place to manage third-party activities E2E ensuring compliance with regulations and company standards; monitor partner performance against agreed-upon metrics and standards, addressing any deviations or deficiencies promptly</p><p>- Conduct periodic assessments of partners to ensure compliance with local requirements and quality standards, implementing corrective actions as necessary; develop risk mitigation strategies and implement controls to minimize risks associated with partner activities</p><p>- Act as point of contact for escalations and issue resolution related to partner activities</p><p>- Stay updated on local regulatory requirements, guidelines, and industry trends to ensure compliance with evolving regulations and communicate to GRA and local team; participating in policy activities with industry groups and trade associations</p><p>- Support regional regulatory TA teams within GRA, for efficient planning and submission preparation according to local requirements and business needs</p><p>- Keep internal data bases up to date with local activity and ensure compliance KPIs are adequately kept on track</p><p></p><ul><li><p>(Internal) stakeholder management and trainings</p></li></ul><p>- Act as primary interface with local partners representing the company&#39;s regulatory interests and fostering positive relationships and ensure that partner, who is acting on CSL behalf, has the appropriate interactions with HAs.</p><p>- Monitor training effectiveness and compliance, ensure proper trainings are developed and in place, providing support and resources as needed to address gaps and improve performance.</p><p></p><p></p><p><b>Parexel-related Responsibilities</b></p><ul><li><p>Meets established metrics as specified in scorecard on an annual basis</p></li><li><p>Completes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, project deliverable archiving, participation in internal initiatives/projects or as a mentor as requested by management</p></li><li><p>Defines self-development activities to keep current within the industry (i.e. maintain membership in a relevant industry and/or scientific/technical association)</p></li><li><p>May participate in thought leadership activities (i.e. present speeches or seminars to industry groups and/or author articles.)</p></li></ul><p></p><p><b><u>Skills:</u></b></p><ul><li><p>Fluent in local language, English, oral and written</p><p></p></li><li><p>Expert MS Office skills</p><p></p></li><li><p>Excellent organizational, time management and interpersonal skills in a global environment.</p><p></p></li><li><p>Ability to work successfully in a complex global matrix organization.</p><p></p></li><li><p>Proven ability to work effectively both independently and in a team.</p><p></p></li><li><p>The expertise, determination and courage to resolve or escalate issues as appropriate.</p><p></p></li><li><p>Subject matter expert in job area typically obtained through advanced education and work experience.</p><p></p></li></ul><p></p><p><b><u>Knowledge and Experience:</u></b></p><ul><li><p>Ideally 5&#43; years of experience in Regulatory Affairs, oversight, governance or compliance roles within pharmaceutical, biotechnology or healthcare industry</p><p></p></li><li><p>Partner management experience: proven experience in managing relationships with third-party vendors,</p><p></p></li><li><p>Ability to work in a highly matrixed organization and to establish successful cross-functional working relationships with people in a wide variety of disciplines and backgrounds, be interpersonally aware and culturally sensitive</p><p></p></li></ul><p></p><p><b><u>Education:</u></b></p><ul><li><p>Relevant bachelor’s degree or equivalent secondary education in e.g., , natural sciences (biology, chemistry or pharmacy), or regulatory affairs</p><p></p></li><li><p>Advanced degree (Master’s or PhD) preferred in e.g., business natural sciences (biology, chemistry or pharmacy) or regulatory affairs</p><p></p></li></ul>