Trumpa antraštė: Regulatory affairs specialist

Darbo sritis: Sveikatos apsauga

Profesija: Kita

Miestas: Vilnius

Tel.: (8 5) 271 51 55

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Aprašymas

<table><tr> <td colspan="2" align="left" class="jobadCompanyName" itemprop="hiringOrganization" itemscope itemtype="http://schema.org/Organization"><B itemprop="name">Teva Baltics / Sicor Biotech, UAB </td> </tr> <tr> <td colspan="2" class="jobadDescription" itemprop="description"></td> </tr> <tr> <td colspan="2" class="jobadPosition" align="left"><b itemprop="title">REGULATORY AFFAIRS SPECIALIST (CMC)</td> </tr> <tr> <td colspan="2" class="jobadDescription" itemprop="description"><p>Organization: Sicor Biotech UAB,  Regulatory Affais group (address: Molėtų pl. 5, Vilnius)</p><p> </p><p><strong>POSITION CHARACTERISTICS:</strong></p><ul> <li>Prepare/review and co-ordinate Chemistry, Manufacturing and Controls (CMC) regulatory filings to various health authorities.</li> <li>Develop, coordinate and implement global regulatory strategies for submissions of Teva's Branded products, from development through post marketing stage.</li> <li>Coordination, preparation and reviewing of CMC sections of registration dossiers, variations and other regulatory documents to ensure compliance with regulatory standards.</li> <li>Review and assess the change controls to establish the regulatory impact and prepare the global strategy for the implementation of the changes.</li> <li>Review of internal CMC controlled documentation having submission impact (stability protocols/reports, justification for changes, risk/benefit assessments, others).</li></ul><p><strong>POSITION REQUIREMENTS: </strong></p><ul> <li>University degree in natural sciences (biology, biochemistry, biotechnology, chemistry) or equivalent;</li> <li>Previous work experience in new drug development, manufacturing or analytics;</li> <li>Working knowledge of EU and/ or US regulations / guidance applicable to registration;</li> <li>Ideally, working knowledge of relevant drug and biologics regulations and guidance including ICH guidelines, GCPs, GMPs, GLPs;</li> <li>Fluent Lithuanian and English language skills (verbal and writing);</li> <li>Advanced computer skills;</li> <li>Ability to work individually or as part of the group on special projects;</li> <li>Ability to work on multiple projects and tasks;</li> <li>Able (and willing) to shift focus among projects at short notice and under tight time requirements;</li> <li>Proactive and diligent.</li></ul><p> </p><p>If you are interested, please send your application and CV to <a href="mailto:cv@sicor.lt">cv@sicor.lt</a> until January 31, 2016.</p></td> </tr> <tr> <td colspan="2" class="jobadSingleLine">Working time  <span itemprop="workHours">Full-time work</span></td> </tr> <tr id="locationrow"> <td colspan="2" class="jobadSingleLine">Location  <span itemprop="jobLocation">Vilnius</span></td> </tr> <tr> <td colspan="2" class="jobadSingleLine">Position  Specialist</td> </tr> <tr> <td colspan="2" class="jobadContact">Contact information:</td> </tr> <tr> <td colspan="2" class="jobadSingleLine">Contact person  </td> </tr> <tr> <td colspan="2" class="jobadSingleLine">Homepage  <a href="http://www.sicor.lt" target="_blank">http://www.sicor.lt</a></td> </tr></table><br />Prašytume nurodyti skelbimo numerį, kai kreipiates!<br />CVO-662439-LT

Kita informacija

• Skelbimas atnaujintas: 2016.01.29 00:58
• Skelbimas įdėtas: 2016.01.13 00:50
• Peržiūros: 203