Senior Regulatory Sciences Specialist

<p><u><b>JOB SUMMARY</b></u></p><p>Senior Regulatory Sciences Specialist is responsible for end-to-end regulatory strategic activities of product registration life-cycle management in compliance with local regulations and Company Standard Operating Procedures (SOPs).</p><p></p><p><b>What You Will Achieve</b></p><p>In this role, you will:</p><p>- Provide strategic product direction and interact with regulatory agencies to expedite approval of pending registrations.</p><p>- Represent regulatory interests to marketing, research project teams, and government agencies throughout the product lifecycle.</p><p>- Develop and submit product registrations, progress reports, supplements, amendments, and periodic experience reports.</p><p>- Provide input to stakeholders for product development in line with business objectives, ensuring strategies are reflected in country plans and aligned with regulatory activities and commercial goals.</p><p>- Support the development of Regulatory Affairs by maintaining internal databases, tracking systems, and document management, and offering regulatory inputs for promotional material approval.</p><p>- Oversee clinical trial applications, manage queries and commitments with stakeholders, and ensure manufacturing and packaging projects are approved on time, maintaining licenses in compliance with local regulations.</p><p></p><p><u><b>JOB RESPONSIBILITIES</b></u></p><p><b>Product registration - NDA, Line Extension (LE) and Plant Master File (PMF)</b></p><p>- Participate the development of the registration plans for NDA, LE and PMF and implement them timely and effectively with the guidance from line manager</p><p>- Partner with cross-functional teams for readiness of the change implementation</p><p><b>Product life-cycle management</b></p><p>- Ensure the assigned products and GMPs are maintained in full compliance with local regulations and company SOPs</p><p>- Ensure key changes of the assigned products are closely communicated with relevant internal stakeholders to ensure readiness of change implementation</p><p><b>Relationship management with stakeholders</b></p><p>- Represent the Regulatory role &amp; objectives to both internal &amp; external partners to promote mutual trust and collaborations</p><p>- Cooperate with relevant stakeholders to share information &amp; provide a good understanding on progress, risk or issues of Regulatory-related activities</p><p>- Attend Association Meetings and get most updated regulatory information</p><p><b>Regulatory compliance</b></p><p>- Complete required trainings and comply with relevant standards to ensure compliance to Pfizer Policy and SOPs</p><p></p><p><u><b>QUALIFICATIONS</b></u></p><p><b>Training &amp; Education Preferred:</b> ​Bachelor degree or above, major in pharmacy or other science-related background.</p><p><b>Prior Experience Preferred:</b> 2-3 years regulatory related experience</p><p><b>English Skill: </b>TOEIC Score≧650</p><p><b>Technical Skill Requirements:</b></p><p>- Professional expertise in local pharmaceutical regulations</p><p>- Good communication skill</p><p>- Problem solving</p><p>- Project Management</p><p>- Teamwork</p><p>- Strategic thinking</p><p>- Negotiation</p><p style="text-align:inherit"></p><p style="text-align:left"><span><span><span><span><span><span><span><span><span>Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.</span></span></span></span></span></span></span></span></span></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>Regulatory Affairs<p></p><p></p>