Senior Regulatory Affairs Specialist

<p style="text-align:left !important">At Johnson &amp; Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at <a target="_blank" href="https://www.jnj.com."><span style="color:#0000ff"><u>jnj.com</u></span></a>.</p><p></p><p>As guided by Our Credo, Johnson &amp; Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson &amp; Johnson, we respect the diversity and dignity of our employees and recognize their merit.</p><p></p><p></p><p style="text-align:left"><b><span><span>Job Function: </span></span></b></p>Regulatory Affairs Group<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b><span><span>Job Sub </span></span><span><span>Function: </span></span></b></p>Regulatory Affairs<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Job Category:</b></p>Professional<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b>All Job Posting Locations:</b></p>Hong Kong, Hong Kong<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Job Description:</b></p><ul><li><p>Take charge of all regulatory submission dossier preparation</p></li><li><p>Timely prepare responses to regulatory agencies questions and other correspondences</p></li><li><p>Be accountable to obtain on track approvals of new registration/change with high quality; and ensure the renewal approvals 100% on time prior to license expires.</p></li><li><p>Maintains the RA database, records and archives all regulatory documentation</p></li><li><p>Timely respond product registration related inquiries from government &amp; customers</p></li><li><p>Review artwork &amp; packaging &amp; labeling, as required.</p></li><li><p>Keep up to date with government legislation as it relates to JNJ, provides implications/interpretations and recommend actions  </p></li><li><p>Coordination of promotional material review and approval</p></li><li><p>Support HK tendering documents</p></li></ul><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p> </p><p> </p><p><b>Required Skills: </b></p><p> </p><p> </p><p><b>Preferred Skills:</b></p>Analytical Reasoning, Business Behavior, Business Writing, Communication, Confidentiality, Data Reporting, Detail-Oriented, Legal Support, Medicines and Device Development and Regulation, Problem Solving, Product Licensing, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Teamwork