Regulatory Affairs Manager

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  "active_status": "active"
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    "title": "Regulatory Affairs Manager",
    "postedOn": "Posted 30+ Days Ago",
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    "logoImage": {
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    "startDate": "2026-06-08",
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    "jobDescription": "<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><u><b><span>Key Accountabilities:</span></b></u></p><p></p><p><b>Project Execution</b></p><ul><li>Typically works within a team environment but may work independently delivering services within their technical area of expertise</li><li>Works within broad project guidelines but liaises closely with more senior colleagues to discuss issues and resolve conflicts</li><li>Demonstrates ability to prioritize work and define steps needed to achieve specified project outcomes</li><li>Capitalizes on opportunities to improve one’s own performance and may provide suggestions for improving project efficiencies and results to the project technical lead</li><li><span>Seeks out information from previous projects, other client work or from colleagues to complete assigned project activities</span></li><li>Produces quality work that meets the expectations of project Team Lead and the client</li><li><span>May serve as a Project Lead for small scale projects or a Work Stream</span></li><li>Lead on larger projects When serving as a Project Lead</li><li>Responsible for project planning and set-up and routinely interacts with the assigned Project Specialist (PS) or Project <span>Manager (PM) to appropriately control the project (e.g. project set-up, forecasting and financial entries, invoicing, etc.)</span></li><li>Functions as the main client contact and ensures accurate project reporting is in place</li><li>Ensures that the project team delivers to meet the client expectations for quality and timeliness</li><li><span>Ensures that appropriate risk identification and issue-escalation procedures are in place</span></li><li>Ensures project specific training compliance of the project team</li><li><span>Ensures and/or manages project financials including provision of accurate revenue forecasts</span></li><li>Ensures that the project team understand and work to the scope of the contract</li><li><span>Identifies new opportunities through Change In Scope or add-</span><span>on business from existing work</span></li><li>Ensures timely project close-out activities are completed</li></ul><p></p><p><b>Consulting Activities and Relationship Management</b></p><ul><li>Follows and implements the organization’s consulting models and methodologies</li><li>Provides technical and/or business consulting services within personal area of expertise</li><li><span>Completes assigned activities within project scope and objectives with an understanding of issues which may impact project profitability</span></li><li>Collaborates with colleagues and client to identify and resolve technical and process issues</li><li>Leverages senior colleagues to discuss and propose resolutions to possible problems or conflicts. Seeks guidance periodically on appropriate methods of executing project activities</li><li>Interacts professionally at multiple levels within a client organization and within Parexel</li><li>Proactively assesses client needs and develops processes and solutions to address issues</li><li>Delivers assigned work and provides services and solutions which results in clients expressing satisfaction with service provided</li><li>Interactions result in clients expressing satisfaction with service provided</li><li>May prepare and/ or deliver presentation with the support of senior colleagues</li><li>May deliver training</li><li>Mentor of junior staff</li><li>Identifies and alerts PC management to opportunities for follow-on business or necessary changes in project scope</li></ul><p></p><p><b>Business Development</b></p><ul><li>Continue to build a network of industry colleagues through relationships formed during project engagements or through other industry experience</li><li><span>Communicates potential new business leads to PC management and account managers</span></li><li>May participate in project scoping calls and/or proposal preparation with the support of senior colleagues</li></ul><p></p><p><b>Parexel-related Activities</b></p><ul><li>Meets established metrics as specified in scorecard on an annual basis</li><li>Completes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, training compliance, project <span>deliverable archiving, participation in internal initiatives/projects or as</span> <span>a mentor as requested by management</span></li><li><span>Defines self-development activities in order to keep current within the industry (i.e. maintain membership in a relevant industry and/or scientific/technical association)</span></li></ul><p></p><p><u><b>Skills:</b></u></p><ul><li><span>Project management knowledge</span></li><li>Client-focused approach to work</li><li><span>Results orientation</span></li><li><span>Teamwork and collaboration skills</span></li><li><span>Consulting skills</span></li><li>Excellent interpersonal and intercultural communication skills, both written and verbal</li><li>Critical thinking and problem-solving skills</li><li>Proficiency in local language and extensive working knowledge of the English language</li></ul><p></p><p><u><b><span>Knowledge and Experience:</span></b></u></p><ul><li>Several years of experience in an industry-related environment</li></ul><p></p><p><u><b><span>Education:</span></b></u></p><ul><li>Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred</li></ul>",
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