Senior Regulatory Affairs Associate (GMP/PAC)

<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><u>Key Accountabilities:</u></b></p><p><span>Act as primary RA representative for local Commercial and medical team: adopt a business perspective, explore opportunities and translate this thinking into actionable plans that fit with strategy.</span></p><p><span>Assess and mitigate impact of changes with local team</span></p><p></p><p><b>Project Execution</b></p><ul><li>Responsible for product and GMP registration dossier preparation and submission of assigned projects.</li><li>Responsible for timely ordering of registration sample, dossier, certificates etc.</li><li>Contribute to the discussion of registration plan with both local and global team.</li><li>Track the registration status in TFDA and timely report to the line manager.</li><li>Address technical questions from TFDA.</li><li>Communicate with global/ regional teams on issues related to product registration, TFDA lab product testing</li><li>Review of promotional materials and labeling.</li><li>Monitor regulation changes and report in timely manner.</li><li>Ensure regulatory activities comply with internal Code of Conduct and SOPs</li><li>Regulatory support to cross functions and department</li><li>Responsible for product and GMP registration dossier preparation and submission of assigned projects.</li><li>Responsible for timely ordering of registration sample, dossier, certificates etc.</li><li>Contribute to the discussion of registration plan with both local and global team.</li><li>Track the registration status in TFDA and timely report to the line manager.</li><li>Address technical questions from TFDA.</li><li>Communicate with global/ regional teams on issues related to product registration, TFDA lab product testing</li><li>Review of promotional materials and labeling.</li><li>Monitor regulation changes and report in timely manner.</li><li>Ensure regulatory activities comply with internal Code of Conduct and SOPs</li><li>Regulatory support to cross functions and department</li><li><p>Works effectively within a team environment but may work independently delivering services within their area of competence</p></li><li><p>Works within broad project guidelines as directed by the project lead and/or technical SMEs</p></li><li><p>Takes initiative to prioritize work to achieve specified project outcomes while confirming alignment with project lead and line manager</p></li><li><p>Capitalizes on opportunities to improve one’s own performance and seeks feedback from the project lead and colleagues</p></li><li><p>Applies information provided by the project lead or senior colleagues to complete assigned project activities</p></li><li><p>Produces quality work that meets the expectations of project lead and the client</p></li><li><p>May serve as a Project Lead for small scale projects or a Work Stream Lead on larger projects, and would be responsible for project planning and set-up and routinely interacts with the assigned Project Specialist (PS) or Project Manager (PM) to appropriately control the project (e.g. project set-up, forecasting and financial entries, invoicing, etc.)</p></li><li><p>Functions as the main client contact and ensures accurate project reporting is in place</p></li><li><p>Ensures that the project team delivers to meet the client expectations for quality and timeliness</p></li><li><p>Ensures that appropriate risk identification and issue-escalation procedures are in place</p></li><li><p>Ensures project specific training compliance of the project team</p></li><li><p>Ensures and/or manages project financials including provision of accurate revenue forecasts</p></li><li><p>Ensures that the project team understand and work to the scope of the contract</p></li><li><p>Identifies new opportunities through Change In Scope or add-on business from existing work</p></li><li><p>Ensures timely project close-out activities are completed</p></li></ul><p></p><p><b>Consulting Activities and Relationship Management</b></p><ul><li><p>Follows and implements the organization’s consulting models and methodologies under the guidance of the project lead and/or Technical SME</p></li><li><p>Delivers consulting services within personal area of expertise under the guidance of the project lead and/or Technical SME</p></li><li><p>Completes assigned activities within project scope and objectives with an understanding of issues which may impact project profitability under the direction of the Project Lead and/or Technical SME</p></li><li><p>Identifies project and internal issues to senior colleagues and Project Lead and/or technical SME and provides proposed solutions</p></li><li><p>Interacts professionally at all working levels within a client organization and within Parexel</p></li><li><p>Identifies project and/or client needs to the Project Lead and or Technical SME and collaborates with senior staff to define a proposed solution</p></li><li><p>Interactions result in clients expressing satisfaction with service provided</p></li><li><p>May assist in preparing and/ or delivering a presentation with the support of senior colleagues</p></li><li><p>Identifies and alerts PC management to opportunities for follow-on business or necessary changes in project scope</p></li></ul><p></p><p><b>Business Development</b></p><ul><li><p>Continue to build a network of industry colleagues through relationships formed during project engagements or through other industry experience</p></li><li><p>Communicates potential new business leads to PC management and account managers</p></li><li><p>May participate in project scoping calls and/or proposal preparation with the support of senior colleagues</p></li></ul><p></p><p><b>Parexel-Related Activities</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, training compliance, project deliverable archiving, participation in internal initiatives/projects as requested by management</p></li><li><p>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)</p></li></ul><p></p><p><b><u>Skills:</u></b></p><ul><li><p>Project management knowledge</p></li><li><p>Client-focused approach to work</p></li><li><p>Results orientation</p></li><li><p>Teamwork and collaboration skills</p></li><li><p>Excellent interpersonal and intercultural communication skills, both written and verbal</p></li><li><p>Critical thinking and problem-solving skills</p></li><li><p>Proficiency in local language and extensive working knowledge of the English language</p></li></ul><p></p><p><b><u>Knowledge and Experience:</u></b></p><ul><li><p>Few years of experience in an industry-related environment</p></li></ul><p></p><p><b><u>Education:</u></b></p><ul><li><p>Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline</p></li></ul><p></p>