Regulatory Affairs Specialist

<p>At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.</p><h3></h3><p></p><h3>The Position</h3><p><span style="font-size:14px">Roche Central Asia is seeking a dedicated and enthusiastic Regulatory Specialist with a structured approach and a growth-oriented mindset. The role offers an engaging and diverse opportunity within a dynamic and adaptable working environment, where you will be responsible for regulatory tasks. The role is temporary  for 3 years  (2026, 2027 and 2028). </span></p><p><span style="font-size:14px">Joining our team means becoming part of an innovative and highly proactive organization.</span></p><p><br /></p><p><b><u><span style="font-size:14px">Role Purpose</span></u></b></p><p><span style="font-size:14px">As a Regulatory Specialist, you will be responsible for coordinating and supporting all regulatory activities in Kazakhstan working together with regulatory partners. </span></p><p><span style="font-size:14px">The position will report directly to the Science Chapter Head </span></p><p><br /></p><p><b><u><span style="font-size:14px">Key Areas of Responsibility</span></u></b></p><p><span style="font-size:14px">Technical support, i.e., filling out national and EAEU websites for all submissions;</span></p><p><span style="font-size:14px">Preparing and Tracking contracts </span><span style="color:#000000"><span style="font-size:14px">with regulatory suppliers and third parties</span></span></p><p><span style="font-size:14px">Downloading dossiers from </span><span style="color:#000000"><span style="font-size:14px">Regulatory Information Management system (RIM), </span></span><span style="font-size:14px">proper completion and closing of events, including the withdrawal process for expired drugs, RIM &#34;cleaning&#34; for proper drug deliver, tracking global dispatches, including SmPC;</span></p><p><span style="font-size:14px">Work in internal and external regulatory systems (RIM, ALPIN, etc)</span></p><p><span style="font-size:14px">Ordering standard samples for laboratory testing</span></p><p><span style="font-size:14px">Labeling of unregistered drugs (Supply Chain support, as well as correspondence with distributors);</span></p><p><span style="color:#000000"><span style="font-size:14px">Request of GMP/CPP documents</span></span></p><p><span style="font-size:14px">Preparing a dossier for localization; full application cycle within the EAEU</span></p><p><span style="font-size:14px">Support for national   procedures</span></p><p><span style="font-size:14px">Partnering with EAEU Hub and Roche HQ for cohesive and efficient operations.</span></p><p><br /></p><p><b><u><span style="font-size:14px">Qualifications and Requirements</span></u></b></p><p><span style="font-size:14px">A master’s degree in pharmacy, Pharmaceutical Sciences, or related fields.</span></p><p><span style="font-size:14px">Experience in regulatory affairs (at least 1 year)</span></p><p><span style="font-size:14px">Strong personality, capable of working effectively in a regulated environment.</span></p><p><span style="font-size:14px">Systematic and structured approach to work, along with flexibility and excellent interpersonal skills.</span></p><p><span style="font-size:14px">A team player with a growth-oriented mindset, capable of working independently as well as collaborating effectively with colleagues.</span></p><p><span style="font-size:14px">Proficiency in English (oral and written).</span></p><p><span style="font-size:14px">Adaptability to change and a proactive attitude towards optimizing processes.</span></p><p><br /></p><p><span style="font-size:14px">We are looking for candidates who are motivated to join a fast-paced team working to a high professional standard and demonstrating the following abilities:</span></p><p><br /></p><p><b> </b></p><p><b> </b></p><p></p><h3>Who we are</h3><p style="text-align:left">A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.</p><p style="text-align:left"><br />Let’s build a healthier future, together.</p><p style="text-align:inherit"></p><p style="text-align:left"><b>Roche is an Equal Opportunity Employer.</b></p>